Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01614769
First received: June 6, 2012
Last updated: February 6, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Placebo Drug: Glimepiride 2 mg Drug: Glimepiride 4 mg Procedure: Hypoglycemic Clamp |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Recovery time from hypoglycemia to euglycemia [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
- Rate of recovery from hypoglycemia to euglycemia [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
- Incremental weighted average blood glucose concentration over 3 hours of hypoglycemic recovery [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | July 2012 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment Sequence: Placebo/Glimepiride 2 mg/Glimepiride 4 mg |
Drug: Placebo
Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 2 mg
One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 4 mg
Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
Procedure: Hypoglycemic Clamp
On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion and a variable-rate dextrose infusion is used to clamp plasma glucose concentrations at 50 mg/dL for 30 minutes.
|
| Experimental: Treatment Sequence: Glimepiride 2 mg/Glimepiride 4 mg /Placebo |
Drug: Placebo
Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 2 mg
One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 4 mg
Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
Procedure: Hypoglycemic Clamp
On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion and a variable-rate dextrose infusion is used to clamp plasma glucose concentrations at 50 mg/dL for 30 minutes.
|
| Experimental: Treatment Sequence: Glimepiride 4 mg/Placebo/Glimepiride 2 mg |
Drug: Placebo
Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 2 mg
One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 4 mg
Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
Procedure: Hypoglycemic Clamp
On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion and a variable-rate dextrose infusion is used to clamp plasma glucose concentrations at 50 mg/dL for 30 minutes.
|
| Experimental: Treatment Sequence: Placebo/Glimepiride 4 mg/Glimepiride 2 mg |
Drug: Placebo
Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 2 mg
One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 4 mg
Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
Procedure: Hypoglycemic Clamp
On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion and a variable-rate dextrose infusion is used to clamp plasma glucose concentrations at 50 mg/dL for 30 minutes.
|
| Experimental: Treatment Sequence: Glimepiride 2 mg/Placebo/Glimepiride 4 mg |
Drug: Placebo
Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 2 mg
One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 4 mg
Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
Procedure: Hypoglycemic Clamp
On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion and a variable-rate dextrose infusion is used to clamp plasma glucose concentrations at 50 mg/dL for 30 minutes.
|
| Experimental: Treatment Sequence: Glimepiride 4 mg/Glimepiride 2 mg/Placebo |
Drug: Placebo
Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 2 mg
One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
Drug: Glimepiride 4 mg
Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
Procedure: Hypoglycemic Clamp
On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion and a variable-rate dextrose infusion is used to clamp plasma glucose concentrations at 50 mg/dL for 30 minutes.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01614769 History of Changes |
| Other Study ID Numbers: | 0000-253 |
| Study First Received: | June 6, 2012 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013