Status:
COMPLETED
Welchol as Monotherapy for Type 2 Diabetes Mellitus
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evalu...
Eligibility Criteria
Inclusion
- Male or female subjects \>= 18 years of age;
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol.
- Diagnosis of Type 2 Diabetes Mellitus;
- HbA1C \>= 7.5% and =\< 9.5 % at screening;
- Fasting C-peptide \>0.5 ng/mL at screening;
- Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy for diabetes for the 3 month period prior to screening;
- Clinically stable in regards to medical conditions other than type 2 diabetes;
- Concomitant medications must be at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period; and
- Fasting glucose =\< 240 mg/dL at randomization
Exclusion
- A history of type 1 diabetes and/or a history of ketoacidosis;
- History of bowel obstruction;
- History of hypertriglyceridemia-induced pancreatitis;
- Fasting serum triglyceride concentrations \>500 mg/dL;
- History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI) motility disorders, or major GI surgery;
- History of insulin use of \>= 2 weeks duration in the previous 3 months or a total of \> 2 months of insulin therapy at any time prior to screening;
- Two or more fasting self-monitored blood glucose (SMBG) levels \>240 mg/dL during the placebo lead-in period.
- Previous treatment with a bile acid sequestrant, including Welchol within the 3 months prior to screening;
- Body mass index (BMI) \>40 kg/m2;
- Weight loss \> 3% in prior 3 months; and
- LDL \<60 mg/dL.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00789737
Start Date
January 1 2009
End Date
December 1 2011
Last Update
February 27 2014
Active Locations (107)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35216
2
Birmingham, Alabama, United States, 35294
3
Montgomery, Alabama, United States, 36117
4
Muscle Shoals, Alabama, United States, 35662