Phase 3
Completed N=357
Welchol as Monotherapy for Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00789737 ↗Enrolled (actual)
357
Serious AEs
2.9%
Results posted
Jan 2014
Primary outcomePrimary: Percent Change in Hemoglobin A1c — -0.41; -0.14 percentage change of hemoglobin A1c — p=0.0369
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 evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Hemoglobin A1c |
-0.41; -0.14 | 0.0369 sig |
| SECONDARY Change in Fasting Plasma Glucose |
-4.6; 5.7 | 0.0373 sig |
| SECONDARY % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units |
33.1; 19.5 | — |
| SECONDARY % Subjects Achieving an HbA1C Goal of <7.0 |
20.0; 13.6 | — |
| SECONDARY % Subjects With a Decrease in FPG >=30 mg/dL |
26.9; 17.8 | — |
| SECONDARY Changes in Total Cholesterol [TC] |
-3.3; 1.8 | — |
| SECONDARY Changes in Low Density Lipoprotein Cholesterol [LDL-C] |
-10.0; 1.2 | <0.00001 sig |
| SECONDARY Changes in High Density Lipoprotein Cholesterol [HDL-C] |
1.7; -0.1 | — |
| SECONDARY Changes in Non-HDL-C |
-4.4; 3.0 | — |
| SECONDARY Changes in Triglycerides [TG] |
15.5; 5.8 | — |
| SECONDARY Changes in Apolipoprotein A-I (apoA-I) |
3.2; 0.9 | — |
| SECONDARY Changes in Apolipoprotein B (apoB) |
-5.6; 0.9 | — |
| SECONDARY Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test |
-9.3; -1.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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 = 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 = 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.
Data sourced from ClinicalTrials.gov (NCT00789737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.