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Phase 1 Completed N=13 Randomized Double-blind Treatment

Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)

Source: ClinicalTrials.gov NCT01106287 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: Number of Participants Who Experienced One or More Adverse Events During the Study — 2; 6; 4; 9 participants

Summary

This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Experienced One or More Adverse Events During the Study
2; 6; 4; 9; 4; 5
PRIMARY
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
0; 0; 0; 0; 0; 0

Eligibility Criteria

Inclusion Criteria

  • Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
  • Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
  • No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
  • In good health (except for Type 2 Diabetes)
  • Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)
  • Nonsmoker

Exclusion Criteria

  • History of stroke, chronic seizure or major neurological disorder
  • History of cancer
  • History of Type 1 Diabetes
  • Recent history of eye infection
  • Glaucoma or blindness
  • Eye surgery (by incision or laser) within the past three months
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01106287). 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.

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