Phase 2
Completed N=685
A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)
Source: ClinicalTrials.gov NCT01217073 ↗Enrolled (actual)
685
Serious AEs
3.2%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline in Plasma A1C Levels at Week 12 — -0.14; -0.36; -0.35; -0.53 Percent — p=<0.001
Summary
The purpose of this study is to assess the hypothesis that treatment with study medication (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5 different doses of omarigliptin to identify which dose is the most effective in the treatment of type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma A1C Levels at Week 12 |
-0.14; -0.36; -0.35; -0.53; -0.57; 0.14 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period |
37.2; 43.5; 36.8; 36.5; 33.3; 31.0 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period |
0.9; 0; 0.9; 0; 3.5; 0.9 | — |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period |
66.8; 65.8 | — |
| PRIMARY Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period |
3.8; 5.3 | — |
| SECONDARY Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12 |
-11.3; -26.0; -27.5; -34.0; -37.3; 7.5 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12 |
1.2; -15.3; -10.6; -9.8; -17.7; 3.7 | <0.001 sig |
| SECONDARY Mean Plasma A1C Level at Baseline of the Extension Period |
8.0; 8.2 | — |
| SECONDARY Change From Baseline in Plasma A1C Levels at Week 78 |
-0.57; -0.55; -0.30; -0.60; -0.46; -0.88 | — |
| SECONDARY Mean 2h-PMG Level at Baseline of the Extension Period |
232.8; 244.5 | — |
| SECONDARY Change From Baseline in 2h-PMG at Week 78 |
-37.0; -21.3; -18.0; -27.6; -43.2; -40.3 | — |
| SECONDARY Mean FPG Level at Baseline of the Extension Period |
169.4; 172.9 | — |
| SECONDARY Change From Baseline in FPG Levels at Week 78 |
-7.4; -11.3; -2.0; -10.0; -0.7; -19.6 | — |
Eligibility Criteria
Inclusion Criteria
The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.
The participant:
- Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age;
- Has a body mass index (BMI) > 20 kg/m^2 and 18 kg/m^2 and <43 kg/m^2;
- Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control;
- Is a male, or a female who is highly unlikely to conceive.
Exclusion Criteria
If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.
The participant:
- Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
- Is on a weight loss program or has started a weight loss medication within the prior 8 weeks;
- Has required insulin therapy within 14 weeks prior to signing informed consent;
- Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease;
- Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease;
- Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder;
- Has a history of malignancy or clinically important hematological disorder
Data sourced from ClinicalTrials.gov (NCT01217073). 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.