Overview

Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)

Status:
Completed
Trial end date:
2013-01-23
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Glimepiride
Hypoglycemic Agents
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.