Phase 2
Completed N=74
A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
Source: ClinicalTrials.gov NCT02004886 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 — -37.9; -65.7; -38.1; -12.0 mg/dL — p=<0.001
Summary
This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 |
-37.9; -65.7; -38.1; -12.0 | <0.001 sig |
| PRIMARY Number of Participants Experiencing an Adverse Event (AE) |
3; 7; 9; 8 | — |
| PRIMARY Number of Participants Discontinuing Study Treatment Due to an AE |
0; 1; 0; 0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-32.5; -57.7; -22.8; -14.1 | 0.04 sig |
| SECONDARY Change From Baseline in Fructosamine at Week 4 |
NA; NA; NA; NA | — |
| SECONDARY Change From Baseline in Fasting C-peptide at Week 4 |
0.1; -0.3; -0.1; -0.0 | 0.751 |
| SECONDARY Change From Baseline in Fasting Insulin at Week 4 |
NA; NA; NA; NA | — |
| SECONDARY Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4 |
-10.5; -15.3; -29.0; -2.8 | 0.253 |
| SECONDARY Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4 |
-128.8; -230.2; -136.7; -39.0 | 0.002 sig |
| SECONDARY Change From Baseline in 3-hour AUC for C-peptide at Week 4 |
1.0; -0.5; -0.2; -0.1 | 0.408 |
| SECONDARY Change From Baseline in 3-hour Insulin Total AUC at Week 4 |
5.3; 6.1; 1.2; 7.8 | 0.857 |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones [i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents])
- male or a female of non-childbearing potential. Women must be postmenopausal or premenopausal and documented surgically sterilized
- A body mass index (BMI) that is > 20 and ≤ 40 kg/m2
Exclusion Criteria
- History of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
- History of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
- Treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
- oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
- History of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
- History of gastrointestinal problems or disorders or extensive bowel or gastric surgery
- History of significant or unstable cardiovascular disease
- History of neoplastic disease
- History of hepatic disease
- History of seizures, epilepsy or other neurologic disease
- History of myelodysplastic or pre-leukemic disorders or other severe hematological disorder
Data sourced from ClinicalTrials.gov (NCT02004886). 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.