Clinical trial NCT01614769: Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Official title: A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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) =\< 40 kg/m\^2.
* At screening visit has a Hemoglobin A1c (HbA1c) of \>= 7% and \< 10% (+/- 0.1%).
* On the morning of randomization at predose has fasting plasma glucose (FPG) \>= 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.

Primary outcomes:
measure: Recovery Time From Hypoglycemia to Euglycemia
timeFrame: From 1 to 180 minutes post hypoglycemic clamp
measure: Rate of Recovery From Hypoglycemia to Euglycemia
timeFrame: From 1 to 180 minutes post hypoglycemic clamp
measure: Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery
timeFrame: From 1 to 180 minutes post hypoglycemic clamp
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: