Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)

NCT00509236 | Completed Phase 3 Results

• 2 other identifiers: 0431-0732007_550
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.

Conditions

Diabetes Mellitus, Type 2; End-Stage Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment

  Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.

  Baseline / Week 54

• Number of Participants With Clinical Adverse Events

  Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.

  54 Week Treatment Period + 28 days

Secondary Outcomes (3)

• Number of Participants With Symptomatic Hypoglycemic Adverse Events

  54 Week Treatment Period + 28 days

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Baseline / Week 54

• Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment

  Baseline / Week 54

Study Arms (2)

Sitagliptin 25 mg

EXPERIMENTAL

Drug: Sitagliptin

Glipizide 2.5 mg - 20 mg

ACTIVE COMPARATOR

Drug: Glipizide

Interventions

Sitagliptin DRUG

25 mg (one 25-mg tablet) once daily

Also known as: MK-0431

Sitagliptin 25 mg

Glipizide DRUG

2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg

Also known as: Glucotrol

Glipizide 2.5 mg - 20 mg

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has T2DM.
• Participant is on dialysis on day of signing informed consent.
• Participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
• Participant has hemoglobin A1c ≥7% and ≤9% measured at or within 2 weeks prior to Visit 4/Week -2.
• Participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.

You may not qualify if:

• Participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
• Participant is losing weight in a weight loss program and is not in the maintenance phase (defined as \<2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
• Participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
• Participant has cirrhosis or active liver disease.
• Participant has been on dialysis for \< 6 months.
• Participant has been diagnosed with a significant cardiovascular disorder and has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.
• Participant has severe active peripheral vascular disease.
• Participant has a history of malignancy ≤ 5 years prior to signing informed consent, or \> 5 years without documentation of remission/cure.
• Participant is under treatment for hyperthyroidism.
• Participant has a hypersensitivity or contraindication to glipizide.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Arjona Ferreira JC, Corry D, Mogensen CE, Sloan L, Xu L, Golm GT, Gonzalez EJ, Davies MJ, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kidney Dis. 2013 Apr;61(4):579-87. doi: 10.1053/j.ajkd.2012.11.043. Epub 2013 Jan 24.

  PMID: 23352379 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Kidney Failure, Chronic

Interventions

Sitagliptin Phosphate; Glipizide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Sulfonylurea Compounds; Sulfones; Sulfur Compounds; 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: July 27, 2007
• First Posted: July 31, 2007
• Study Start: October 19, 2007
• Primary Completion: March 14, 2011
• Study Completion: March 14, 2011
• Last Updated: May 12, 2017
• Results First Posted: May 3, 2012

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share