Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01293669|
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : September 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: TC-6987 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Study of Glycemic Control, Safety, Tolerability and Pharmacokinetic Parameters of TC-6987 Monotherapy in Subjects With Type 2 Diabetes Mellitus|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
TC-6987-23 (TC-6987 HCl) as experimental treatment: 20 mg loading dose (2 capsules) on Day 1 and 10 mg (1 capsule) on Days 2 to 28 (dose expressed as free base). Each dose will be given once daily.
|Placebo Comparator: Placebo||
Matching placebo: Mode of administration: p.o. (microcrystalline cellulose in capsule) given once daily.
- Changes in fasting plasma glucose (FPG) [ Time Frame: Day 1 and Week 4 ]The primary efficacy endpoint will be FPG values obtained at Week 4 compared to Day 1 (baseline). This change from baseline will be analyzed using MMRM techniques with an alpha of 0.10 (one-sided), to examine differences between the TC-6987 and placebo treatment cohorts. This change from baseline will be analyzed using the primary efficacy endpoints for the mITT analysis set. The efficacy analyses based on the Per Protocol (PP) analysis set will be considered secondary.
- Change in FPG from Day 1 (Baseline) at each time point [ Time Frame: Day 1, Week 1 and Week 4 ]Change in FPG from Day 1 (Baseline) compared to weeks 1 and 4
- Change in FPG and insulin from Day 1 (Baseline) at each time point [ Time Frame: Day 1, Week 1 and Week 4 ]Change in FPG and insulin from Day 1 (Baseline) compared to weeks 1 and 4
- Change in AUC FPG from Day 1 (Baseline) and at Week 4 [ Time Frame: Day 1 and Week 4 ]Change in AUC FPG from Day 1 (Baseline) compared to weeks 1 and 4
- Change in AUC insulin from Day 1 (Baseline) at Week 4 [ Time Frame: Day 1 and Week 4 ]Change in AUC insulin from Day 1 (Baseline) compared to week 4
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293669
|Principal Investigator:||Aaron Vinik, MD||Strelitz Diabetes Center, Eastern Virginia Medical School|