A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

NCT00701090 | Completed Phase 3 Results

• 2 other identifiers: 0431-8032008_503
• Study Type: interventional
• Target: 1,035
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Conditions

Type 2 Diabetes Mellitus, Non Insulin Dependent; Diabetes Mellitus, Non-Insulin-Dependent

Keywords

Type 2 Diabetes Mellitus; Non Insulin Dependent

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 30

  Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.

  Week 0 to Week 30

Secondary Outcomes (5)

• Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30

  Week 0 to Week 30

• Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30

  Week 0 to Week 30

• Change From Baseline in Body Weight at Week 30

  Week 0 to Week 30

• Percent of Patients With A1C <7.0% at Week 30

  Week 30

• Percent of Patients With A1C <6.5% at Week 30

  Week 30

Study Arms (2)

1

EXPERIMENTAL

sitagliptin

Drug: sitagliptin; Drug: open-label metformin

2

ACTIVE COMPARATOR

glimepiride

Drug: Comparator: glimepiride; Drug: open-label metformin

Interventions

sitagliptin DRUG

Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks

Also known as: Januvia

1

Comparator: glimepiride DRUG

glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.

2

open-label metformin DRUG

open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

Also known as: metformin

1; 2

Eligibility Criteria

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

You may qualify if:

• years or older
• Diagnosed with type 2 diabetes
• On a stable dose of metformin of at least 1500 mg per day

You may not qualify if:

• History of type 1 diabetes
• Pregnant
• HIV positive
• On a weight loss program or medication
• Has a history of blood disorder, certain cancers, heart, liver or kidney disease

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Arechavaleta R, Seck T, Chen Y, Krobot KJ, O'Neill EA, Duran L, Kaufman KD, Williams-Herman D, Goldstein BJ. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011 Feb;13(2):160-8. doi: 10.1111/j.1463-1326.2010.01334.x.

  PMID: 21199268 RESULT

• Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.

  PMID: 25633134 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin

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; Biguanides; Guanidines; Amidines; Organic Chemicals

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 Monitor

  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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 10, 2017
• Results First Posted: October 5, 2010

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share