Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)

NCT01462266 | Completed Phase 3 Results

• 1 other identifier: 0431-260
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with metformin. The primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of insulin relative to placebo.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Daily Insulin Dose at Week 24

  Change in daily insulin dose following 24 weeks of therapy (i.e., daily insulin dose at Week 24 minus daily insulin dose at baseline)

  Baseline and Week 24

Secondary Outcomes (4)

• Change From Baseline in Hemoglobin A1c (A1C) at Week 24

  Baseline and Week 24

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

• Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study

  Up to 24 weeks

• Time to Achieve the Fasting Glucose Target

  Up to 24 weeks

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Sitagliptin 100 mg once daily

Drug: Sitagliptin; Biological: Insulin Glargine; Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo to sitagliptin once daily

Drug: Comparator: Placebo; Biological: Insulin Glargine; Drug: Metformin

Interventions

Sitagliptin DRUG

Sitagliptin 100 mg tablet once daily for 24 weeks

Also known as: Januvia

Sitagliptin

Comparator: Placebo DRUG

Placebo to sitagliptin once daily for 24 weeks

Placebo

Insulin Glargine BIOLOGICAL

Participants on insulin glargine or another insulin regimen for at least 10 weeks prior to screening will continue or switch to open-label insulin glargine once-daily in the evening for the duration of the study.

Placebo; Sitagliptin

Metformin DRUG

Participants on metformin oral tablet(s) at a dose of at least 1500 mg/day for at least 10 weeks prior to screening will continue receiving metformin at their current dose for the duration of the study.

Also known as: Glucophage

Placebo; Sitagliptin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has type 2 diabetes mellitus
• has one of the following criteria:
• diagnosed with diabetes after age 40 years and insulin therapy was initiated at least 3 years following diagnosis
• if diagnosed with diabetes under age 40 years or insulin started earlier than 3 years after diagnosis, has a fasting C-peptide greater than 0.7 ng/mL
• must be at least 18 years of age and less than or equal to 80 years of age (for participants in India: must be at least 18 years of age and less than or equal to 65 years of age)
• on a stable regimen of insulin for at least 10 weeks with or without metformin (at least 1500 mg/day) and/or sulfonylurea for at least 10 weeks
• is highly unlikely to become pregnant (not of reproductive potential or agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication

You may not qualify if:

• has been treated with a dipeptidyl peptidase IV (DPP-4) inhibitor, a thiazolidinedione (TZD), or a glucagon-like peptide-1 (GLP-1) mimetic or analogue, within the past 12 weeks
• currently on treatment with daily use (one or more injections per day) of a
• pre-prandial short-acting or rapid-acting insulin alone or as part of a basal/bolus insulin regimen
• has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy
• has a history of 2 or more episodes of hypoglycemia resulting in seizure,
• coma, or loss of consciousness, - or - has had recurrent (≥3 times per week) episodes of hypoglycemia over the past 8 weeks
• has a history of ketoacidosis
• is not appropriate for or does not agree to target a fasting glucose of 72-100 mg/dL \[4.0-5.6 mmol/L\]
• is on or likely to require treatment with corticosteroids
• has undergone a surgical procedure within 4 weeks or has planned major surgery during the study
• is currently being treated for hyperthyroidism or is on thyroid hormone
• therapy and has not been on a stable dose for at least 6 weeks
• has a history of active liver disease (other than non-alcoholic hepatic
• steatosis)
• has had new or worsening signs or symptoms of coronary heart disease or

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Mathieu C, Shankar RR, Lorber D, Umpierrez G, Wu F, Xu L, Golm GT, Latham M, Kaufman KD, Engel SS. A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Co-Administration of Sitagliptin with Intensively Titrated Insulin Glargine. Diabetes Ther. 2015 Jun;6(2):127-42. doi: 10.1007/s13300-015-0105-3. Epub 2015 Mar 28.

  PMID: 25820927 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Insulin Glargine; 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; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; 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

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: October 27, 2011
• First Posted: October 31, 2011
• Study Start: January 13, 2012
• Primary Completion: June 6, 2013
• Study Completion: June 7, 2013
• Last Updated: August 17, 2018
• Results First Posted: April 8, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share