Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)

NCT02318693 | Completed Phase 4 Results

• 2 other identifiers: 0431-355152867
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM) after 13 days of treatment.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13

  MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.

  Baseline (Day -2) and Day 13

Secondary Outcomes (4)

• Change From Baseline in the Standard Deviation of Blood Glucose Levels

  Baseline (Day -2) and Day 13

• Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal

  Baseline (Day -2) and Day 13

• Change From Baseline in 24-hour Mean Glucose Level

  Baseline (Day -2) and Day 13

• Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)

  Baseline (Day -2) and Day 13

Study Arms (2)

Sitagliptin 50 mg

EXPERIMENTAL

Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.

Drug: Sitagliptin

Glibenclamide 2.50 mg TDD

ACTIVE COMPARATOR

Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.

Drug: Glibenclamide

Interventions

Sitagliptin DRUG

Sitagliptin 50 mg orally once a day before breakfast for 14 days

Also known as: MK-0431

Sitagliptin 50 mg

Glibenclamide DRUG

Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days

Glibenclamide 2.50 mg TDD

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese participants with a diagnosis of Type 2 diabetes mellitus

You may not qualify if:

• History of Type 1 diabetes mellitus or ketoacidosis
• History of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Suzuki R, Eiki JI, Moritoyo T, Furihata K, Wakana A, Ohta Y, Tokita S, Kadowaki T. Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naive Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Sep;20(9):2274-2281. doi: 10.1111/dom.13364. Epub 2018 Jun 11.

  PMID: 29770541 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Glyburide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 17, 2014
• Study Start: February 4, 2015
• Primary Completion: December 15, 2015
• Study Completion: December 15, 2015
• Last Updated: August 21, 2018
• Results First Posted: January 23, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share