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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01614769

First received: June 6, 2012

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 6, 2012
Last Updated Date	February 6, 2013
Start Date ^ICMJE	July 2012
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 7, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01614769 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Official Title ^ICMJE	A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus
Brief Summary	This study aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Treatment Sequence: Placebo/Glimepiride 2 mg/Glimepiride 4 mg Interventions: Drug: Placebo Drug: Glimepiride 2 mg Drug: Glimepiride 4 mg Procedure: Hypoglycemic Clamp Experimental: Treatment Sequence: Glimepiride 2 mg/Glimepiride 4 mg /Placebo Interventions: Drug: Placebo Drug: Glimepiride 2 mg Drug: Glimepiride 4 mg Procedure: Hypoglycemic Clamp Experimental: Treatment Sequence: Glimepiride 4 mg/Placebo/Glimepiride 2 mg Interventions: Drug: Placebo Drug: Glimepiride 2 mg Drug: Glimepiride 4 mg Procedure: Hypoglycemic Clamp Experimental: Treatment Sequence: Placebo/Glimepiride 4 mg/Glimepiride 2 mg Interventions: Drug: Placebo Drug: Glimepiride 2 mg Drug: Glimepiride 4 mg Procedure: Hypoglycemic Clamp Experimental: Treatment Sequence: Glimepiride 2 mg/Placebo/Glimepiride 4 mg Interventions: Drug: Placebo Drug: Glimepiride 2 mg Drug: Glimepiride 4 mg Procedure: Hypoglycemic Clamp Experimental: Treatment Sequence: Glimepiride 4 mg/Glimepiride 2 mg/Placebo Interventions: Drug: Placebo Drug: Glimepiride 2 mg Drug: Glimepiride 4 mg Procedure: Hypoglycemic Clamp
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	10
Completion Date	January 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01614769
Other Study ID Numbers ^ICMJE	0000-253
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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