Phase 1
N=10
Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01614769 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Recovery Time From Hypoglycemia to Euglycemia — 74.49; 88.90; 109.81 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Drug); Glimepiride 2 mg (Drug); Glimepiride 4 mg (Drug); Hypoglycemic Clamp (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery Time From Hypoglycemia to Euglycemia |
74.49; 88.90; 109.81 | — |
| PRIMARY Rate of Recovery From Hypoglycemia to Euglycemia |
0.32; 0.22; 0.19 | — |
| PRIMARY Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery |
22.61; 17.58; 15.34 | — |
Summary
This study aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus. The primary objective is to estimate the time taken by participants to recover from hypoglycemia to euglycemia after treatment with either 2 mg or 4 mg of glimepiride when compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Has clinically confirmed diagnosis of type 2 diabetes mellitus (T2DM) controlled by diet and exercise alone, or treated by metformin only with same dose for >= 12 weeks prior to screening visit.
- Females of reproductive potential who demonstrate nongravid state, agree to use (and/or have partner use) two acceptable methods of birth control starting at least two weeks prior to study, throughout study, and at least two weeks after last dose of study drug.
- Females of non-reproductive potential, post menopausal, status post hysterectomy, oophorectomy or tubal ligation.
- Is in good health, other than T2DM.
- Has been a nonsmoker and/or non user of nicotine-containing products for the previous 6 months. If discontinued use for previous 3 months, may be enrolled at investigator's discretion.
- Will follow American Heart Association weight maintaining diet and exercise program or equivalent beginning 2 weeks prior to study until poststudy visit.
- At screening visit has a Body Mass Index (BMI) = = 7% and = 126 mg/dL, and =< 250 mg/dL.
Exclusion Criteria
- Has a history of stroke, chronic seizures, or major neurological disorder.
- Has a history of any illness that might confound the results of the study or pose additional risk to the participant.
- Has a history of type 1 diabetes mellitus, ketoacidosis, C-peptide =< 0.8 ng/mL, secondary forms of diabetes or diabetic complications.
- Has a history of neoplastic disease.
- Is a nursing mother.
- Has been treated =< one year of screening visit with sulfonylurea agents, meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogs, or insulin.
- Has received treatment within =< 12 weeks of screening visit with a peroxisome proliferator-activated receptor γ (PPARγ) agonist.
- Is taking medications for a co-morbid condition or anticipates taking new medications beginning 2 weeks prior to study.
- Consumes excessive amounts of alcohol or caffeinated beverages.
- Is a regular user of illicit drugs, or has a history of drug abuse within the previous 6 months.
- Has had major surgery, lost 500 mL of blood, or participated in another investigational study within 4 weeks prior to screening visit.
- Is on a weight loss program, but not in the maintenance phase, or treated with a weight loss medication within 8 weeks of prestudy visit.
- Has a history of severe allergies, anaphylactic reaction or intolerability to drugs, food, insulin, glimepiride or sulfonamide derivatives.
Data sourced from ClinicalTrials.gov (NCT01614769). 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.