Clinical trial NCT00481663: A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Finding Study of Once-Daily Dosing of Sitaglipin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type II Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 555
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).


Eligibility criteria: Inclusion Criteria:

* Men and non-pregnant women
* Fasting plasma glucose \>= 130 mg/dL
* HbA1c \>=6.5% and \>10.0%

Exclusion Criteria:

* You have a history of type I diabetes
* You are on a weight loss program with ongoing weight loss or taking weight loss medication
* You have had surgery within 30 days
* You hvae hepatitis B or C.

Primary outcomes:
measure: Change from Baseline in HbA1C at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants Who Experienced One or More Adverse Events (AE) up to Week 14
timeFrame: Up to Week 14
measure: Number of Participants Who Experienced One or More AE up to Week 54
timeFrame: Up to Week 54
measure: Number of Participants Who Experienced One or More AE up to Week 108
timeFrame: Up to Week 108
measure: Number of Participants Who Experienced One or More AE up to Week 160
timeFrame: Up to Week 160
measure: Number of participants Who Discontinued Study Treatment Due to An AE up to Week 12
timeFrame: Up to Week 12
measure: Number of participants Who Discontinued Study Treatment Due to An AE up to Week 52
timeFrame: Up to Week 52
measure: Number of participants Who Discontinued Study Treatment Due to An AE up to Week 106
timeFrame: Up to Week 106
measure: Number of participants Who Discontinued Study Treatment Due to An AE up to Week 158
timeFrame: Up to Week 158
Secondary outcomes:
measure: Change from Baseline in HbA1C at Week 52
timeFrame: Baseline and Week 52
measure: Change from Baseline in HbA1C at Week 106
timeFrame: Baseline and Week 106
measure: Change from Baseline in HbA1C at Week 158
timeFrame: Baseline and Week 158
measure: Change from Baseline in Fasting Plasma Glucose (FPG) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in FPG at Week 52
timeFrame: Baseline and Week 52
measure: Change from Baseline in FPG at Week 106
timeFrame: Baseline and Week 106
measure: Change from Baseline in FPG at Week 158
timeFrame: Baseline and Week 158
measure: Change from Baseline in Body Weight at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Body Weight at Week 52
timeFrame: Baseline and Week 52
measure: Change from Baseline in Body Weight at Week 106
timeFrame: Baseline and Week 106
measure: Change from Baseline in Body Weight at Week 158
timeFrame: Baseline and Week 158
measure: Change From Baseline in Serum Fructosamine at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 52
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hanefeld M, Herman GA, Wu M, Mickel C, Sanchez M, Stein PP; Sitagliptin Study 014 Investigators. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr Med Res Opin. 2007 Jun;23(6):1329-39. doi: 10.1185/030079907X188152. Epub 2007 Apr 30.