Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Intervention: Placebo; Glimepiride 2 mg; Glimepiride 4 mg; Hypoglycemic Clamp
Intervention description: Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.; One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.; Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.; On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.
Intervention MeSH terms: Glimepiride; Hypoglycemic Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

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.