Click here to close now.


News Feed Item

New Data Demonstrated Efficacy and Safety of Initial Combination Therapy with Welchol(R) (colesevelam HCl) and Metformin in Drug-Naive Adult Type 2 Diabetes Patients

Treatment with Welchol and Metformin Significantly Improved Patients' Glycemic and Lipid Control

PARSIPPANY, N.J., June 26 /PRNewswire/ -- Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C). In the study, treatment with Welchol plus metformin significantly reduced mean A1C levels by 1.1 percent and LDL-C levels by 21 percent. In addition, approximately two-thirds of patients who received Welchol plus metformin achieved the American Diabetes Association (ADA)'s glycemic goal of A1C levels less than 7 percent, which was statistically significant compared with metformin plus placebo alone.(1) Results of the randomized, double-blind, placebo-controlled study were presented today at the 70th Scientific Sessions of the ADA in Orlando.

"In this study, early intervention with Welchol and metformin significantly reduced A1C and LDL cholesterol levels, two important risk factors for cardiovascular disease, in drug-naive adult type 2 diabetes patients with high cholesterol," said Yehuda Handelsman, MD, FACP, FACE, Medical Director of the Metabolic Institute of America in Tarzana, Calif. and investigator of the study. "Notably, these data indicate that initial combination therapy with Welchol and metformin may represent a safe and effective option to help patients with type 2 diabetes reach glycemic and lipid goals."

About 23.6 million, or 8 percent of people in the United States, have diabetes, and approximately 90 to 95 percent of people diagnosed with diabetes have type 2 diabetes.(2) The ADA and the American College of Cardiology emphasize that it is critical to reduce both A1C and LDL cholesterol levels, as more than 50 percent of adults with type 2 diabetes also have elevated LDL cholesterol, greatly increasing their risk of cardiovascular disease.(3,4,5) The effect of Welchol on cardiovascular morbidity and mortality has not been determined.

"As the only medication approved to treat both A1C and LDL-C in adults with type 2 diabetes and primary hyperlipidemia, Welchol addresses both of these chronic health conditions and provides physicians with a unique therapeutic approach for the comorbid patient," said Jay M. Feingold, MD, PhD, Vice President of Medical Affairs at Daiichi Sankyo, Inc. "We are encouraged by these study results, which reinforce the benefits of Welchol for treating adult patients with type 2 diabetes and/or elevated LDL cholesterol."

About the Study (Posters #684 and #633)(1,6)

The randomized, double-blind, placebo-controlled, parallel-group study was conducted at approximately 38 sites within the U.S., Mexico, Colombia, and India, and included a three-week screening period to confirm disease diagnosis followed by 16 weeks of randomized treatment. The study evaluated patients aged 18 to 79 years diagnosed with type 2 diabetes (A1C 6.5 to 10.0 percent, inclusive) and who were drug-naive - defined as never having received treatment for their diabetes, or not having received diabetes medication for three months prior to screening - with LDL cholesterol levels greater than or equal to 100 mg/dL and triglyceride levels less than 500 mg/dL. In total, 286 patients with type 2 diabetes and high cholesterol were randomized to receive either Welchol (colesevelam HCl) 3.75 g/d (n=145) or placebo (n=141) along with open-label metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter). Mean baseline A1C levels were 7.8 percent in the Welchol plus metformin group and 7.5 percent in the metformin plus placebo group.

The study found that initial combination therapy with Welchol and metformin reduced mean A1C levels by 1.1 percent compared with patients receiving metformin plus placebo (-0.8 percent), resulting in a mean treatment difference of -0.3 percent (p<0.01). The study also showed that 67 percent of patients (n=66) achieved the A1C target of less than 7 percent with Welchol plus metformin, compared with 56 percent of patients (n=53) receiving metformin plus placebo, a statistically significant difference (p<0.01). Additionally, 48 percent of patients (n=61) in the Welchol group attained LDL cholesterol less than 100 mg/dL compared with 18 percent of patients (n=24) in the metformin plus placebo group (p<0.0001).

Welchol in combination with metformin also resulted in significantly greater mean reductions in LDL cholesterol levels (16 percent), mean total cholesterol levels (6 percent), mean non-HDL cholesterol (8 percent), mean apolipoprotein B (8 percent), and median high sensitivity C-reactive protein (hs-CRP) (17 percent) compared with patients treated with metformin plus placebo, (p<0.01 for all). In the study, Welchol plus metformin increased triglycerides by 19 percent (p<0.001) compared with metformin plus placebo.

Results from a safety analysis of this study showed that initial combination therapy with Welchol and metformin was well-tolerated and had a safety profile similar to that of metformin monotherapy. Compliance with the individual treatment components was greater than 90 percent for both groups. In patients receiving Welchol plus metformin, the most common gastrointestinal adverse events were diarrhea (12 percent) and nausea (12 percent); the most common non-gastrointestinal adverse events were headache (8 percent), influenza (8 percent), and dizziness (6 percent). Mild hypoglycemia was reported in two patients treated with Welchol (colesevelam HCl) and metformin compared with three patients receiving metformin and placebo. By the end of the study, weight decreased by 2.1 kg in each group.

About Welchol

Approved in 2000 to lower LDL cholesterol and in 2008 as add-on therapy for glycemic control in adults with type 2 diabetes, Welchol is approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to reduce elevated LDL-C and improve glycemic control in adults with primary hyperlipidemia and type 2 diabetes, two chronic health conditions. Welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. Welchol has not been studied in type 2 diabetes as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor and has not been extensively studied in combination with thiazolidinediones. Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. Welchol is available in two formulations, Welchol tablets and Welchol® for Oral Suspension.

In clinical studies of adult patients with type 2 diabetes, Welchol lowered A1C, fasting plasma glucose and LDL-C, important risk factors for cardiovascular disease.* In clinical studies of patients with elevated LDL-C, Welchol lowered LDL-C when used as monotherapy, when added to statin therapy, or as initial combination with statin therapy.(7)

*The effect of Welchol on cardiovascular morbidity and mortality has not been determined.



Welchol is indicated as an adjunct to diet and exercise to:

  • reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethylglutaryl-coenzyme (HMG CoA) reductase inhibitor (statin)
  • improve glycemic control in adults with type 2 diabetes mellitus

Important Limitations of Use

  • Welchol should not be used for glycemic control in type 1 diabetes or for the treatment of diabetic ketoacidosis
  • Welchol has not been studied in type 2 diabetes as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor and has not been extensively studied in combination with thiazolidinediones
  • Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias


Welchol is contraindicated in individuals with a history of bowel obstruction, those with serum triglyceride (TG) concentrations of >500 mg/dL, or with a history of hypertriglyceridemia-induced pancreatitis.

Warnings and Precautions

The effect of Welchol on cardiovascular morbidity and mortality has not been determined.

Welchol can increase serum TG concentrations particularly when used in combination with sulfonylureas or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL.

Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients on vitamin supplements should take their vitamins at least 4 hours prior to Welchol. Caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies.

Caution should also be exercised when treating patients with gastroparesis, gastrointestinal motility disorders, a history of major gastrointestinal tract surgery, and when treating patients with dysphagia and swallowing disorders.

Welchol reduces gastrointestinal absorption of some drugs. Drugs with a known interaction with colesevelam (cyclosporine, glyburide, levothyroxine, and oral contraceptives [ethinyl estradiol, norethindrone]) should be administered at least 4 hours prior to Welchol. Drugs that have not been tested for interaction with colesevelam, especially those with a narrow therapeutic index, should also be administered at least 4 hours prior to Welchol. Alternatively, the physician should monitor drug levels of the co-administered drug.

To avoid esophageal distress, Welchol for Oral Suspension should not be taken in its dry form.

Due to tablet size, Welchol for Oral Suspension is recommended for, but not limited to, any patient who has difficulty swallowing tablets.

Phenylketonurics: Welchol for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose.

Adverse Reactions

In clinical trials, the adverse reactions observed in >/= 2% of patients, and more commonly with Welchol than placebo, regardless of investigator assessment of causality seen in:

  • Adults with Primary Hyperlipidemia were: constipation (11.0% vs 7.0%), dyspepsia (8.3% vs 3.5%), nausea (4.2% vs 3.9%), accidental injury (3.7% vs 2.7%), asthenia (3.6% vs 1.9%), pharyngitis (3.2% vs 1.9%), flu syndrome (3.2% vs 3.1%), rhinitis (3.2% vs 3.1%), and myalgia (2.1% vs 0.4%)
  • Adult patients with Type 2 Diabetes were: constipation (8.7% vs 2.0%), nasopharyngitis (4.1% vs 3.6%), dyspepsia (3.9% vs 1.4%), hypoglycemia (3.0% vs 2.3%), nausea (3.0% vs 1.4%), and hypertension (2.8% vs 1.6%)

Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship:

  • Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol
  • Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol
  • Elevated thyroid-stimulating hormone (TSH) has been reported in patients receiving thyroid hormone replacement therapy


Welchol is Pregnancy Category B.

Please visit for full Prescribing Information on Welchol.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or call 1-800-FDA-1088.

For more information on Welchol, call 877-4-DSPROD (877-437-7763), or go to the Welchol web site at

For patients having difficulty affording their Welchol (colesevelam HCl) medication, please call the Daiichi Sankyo, Inc. Open Care Patient Assistance Program at 1-866-268-7327 for more information or visit

About Daiichi Sankyo

In keeping with its vision of becoming a "Global Pharma Innovator," the Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of customers in both developed and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Company, Ltd. For more information on Daiichi Sankyo, Inc., please visit


  1. Rosenstock J et al. Initial Combination Therapy with Metformin + Colesevelam Safely Achieves Glycemic and Lipid Goals with Less Diarrhea in Early Type 2 Diabetes Mellitus. Poster at the 70th Scientific Sessions of the American Diabetes Association (ADA), Orlando (June 25-29, 2010).
  2. Center for Disease Control, National Diabetes Fact Sheet 2007. Accessed June 1, 2010.
  3. Brunzell JD, Davidson M, Furberg CD, et al. Lipoprotein management in patients with cardiometabolic risk: consensus statement from the American Diabetes Association and the American College of Cardiology Foundation. Diabetes Care. 2008;31(4):811-822.
  4. Buse JB, Ginsberg HN, Bakris GL, et al. Primary Prevention of Cardiovascular Diseases in People With Diabetes Mellitus: A Scientific Statement From the American Heart Association and the American Diabetes Association. Circulation. 2007;115:114-126. Accessed June 1, 2010.
  5. Cheung BMY et al. Diabetes Prevalence and Therapeutic Target Achievement in the United States, 1999 to 2006. The American Journal of Medicine. 2009;122:443-453.
  6. Abby SL et al. The Safety and Tolerability of Metformin + Colesevelam in Drug-Naive Patients with Early Type 2 Diabetes Mellitus. Poster at the 70th Scientific Sessions of the American Diabetes Association (ADA), Orlando (June 25-29, 2010).
  7. Welchol Prescribing Information. Available at:

Copyright 2010, Daiichi Sankyo, Inc. all rights reserved: DSWC10001055

SOURCE Daiichi Sankyo

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The Internet of Things (IoT) is about the digitization of physical assets including sensors, devices, machines, gateways, and the network. It creates possibilities for significant value creation and new revenue generating business models via data democratization and ubiquitous analytics across IoT networks. The explosion of data in all forms in IoT requires a more robust and broader lens in order to enable smarter timely actions and better outcomes. Business operations become the key driver of I...
Organizations from small to large are increasingly adopting cloud solutions to deliver essential business services at a much lower cost. According to cyber security experts, the frequency and severity of cyber-attacks are on the rise, causing alarm to businesses and customers across a variety of industries. To defend against exploits like these, a company must adopt a comprehensive security defense strategy that is designed for their business. In 2015, organizations such as United Airlines, Sony...
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, discussed why containers should be paired with new architectural practices such as microservices rathe...
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and a...
It’s been proven time and time again that in tech, diversity drives greater innovation, better team productivity and greater profits and market share. So what can we do in our DevOps teams to embrace diversity and help transform the culture of development and operations into a true “DevOps” team? In her session at DevOps Summit, Stefana Muller, Director, Product Management – Continuous Delivery at CA Technologies, answered that question citing examples, showing how to create opportunities for ...
As more and more data is generated from a variety of connected devices, the need to get insights from this data and predict future behavior and trends is increasingly essential for businesses. Real-time stream processing is needed in a variety of different industries such as Manufacturing, Oil and Gas, Automobile, Finance, Online Retail, Smart Grids, and Healthcare. Azure Stream Analytics is a fully managed distributed stream computation service that provides low latency, scalable processing of ...
Everyone talks about continuous integration and continuous delivery but those are just two ends of the pipeline. In the middle of DevOps is continuous testing (CT), and many organizations are struggling to implement continuous testing effectively. After all, without continuous testing there is no delivery. And Lab-As-A-Service (LaaS) enhances the CT with dynamic on-demand self-serve test topologies. CT together with LAAS make a powerful combination that perfectly serves complex software developm...
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Any Ops team trying to support a company in today’s cloud-connected world knows that a new way of thinking is required – one just as dramatic than the shift from Ops to DevOps. The diversity of modern operations requires teams to focus their impact on breadth vs. depth. In his session at DevOps Summit, Adam Serediuk, Director of Operations at xMatters, Inc., will discuss the strategic requirements of evolving from Ops to DevOps, and why modern Operations has begun leveraging the “NoOps” approa...
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
In today's digital world, change is the one constant. Disruptive innovations like cloud, mobility, social media, and the Internet of Things have reshaped the market and set new standards in customer expectations. To remain competitive, businesses must tap the potential of emerging technologies and markets through the rapid release of new products and services. However, the rigid and siloed structures of traditional IT platforms and processes are slowing them down – resulting in lengthy delivery ...
SYS-CON Events announced today that IceWarp will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
In their Live Hack” presentation at 17th Cloud Expo, Stephen Coty and Paul Fletcher, Chief Security Evangelists at Alert Logic, will provide the audience with a chance to see a live demonstration of the common tools cyber attackers use to attack cloud and traditional IT systems. This “Live Hack” uses open source attack tools that are free and available for download by anybody. Attendees will learn where to find and how to operate these tools for the purpose of testing their own IT infrastructu...
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, will discuss how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a prac...
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.