Phase 1
Completed N=70
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
Source: ClinicalTrials.gov NCT00511472 ↗Enrolled (actual)
70
Serious AEs
2.9%
Results posted
Jul 2012
Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event During the Study — 46; 21 participants
Summary
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event During the Study |
46; 21 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event - Titration Scheme 1 |
20; 11 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event - Titration Scheme 2 |
22; 10 | — |
| SECONDARY 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7 |
155.5; 151.3; 201.6 | 0.001 sig |
| SECONDARY Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period |
20; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female (of non-childbearing potential) between 18 to 70 years of age
- Diagnosed with Type 2 Diabetes and currently being treated with basal insulin
- Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules
Exclusion Criteria
- History of Type 1 diabetes
- Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
- History of severe hypoglycemia
- Allergic to insulin
Data sourced from ClinicalTrials.gov (NCT00511472). 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.