Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2, End-Stage Kidney Disease

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Sitagliptin

Glipizide

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sitagliptin 25 mg

Glipizide 2.5 mg - 20 mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Number of Participants With Clinical Adverse Events

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

Secondary Outcome Measures

Number of Participants With Symptomatic Hypoglycemic Adverse Events

A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.

Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.

Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment

Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated.

Full Information

NCT ID

NCT00509236

First Posted

July 27, 2007

Last Updated

April 7, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00509236

Brief Title

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

Official Title

A Multicenter, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

October 19, 2007 (Actual)

Primary Completion Date

March 14, 2011 (Actual)

Study Completion Date

March 14, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, End-Stage Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitagliptin 25 mg

Arm Type

Experimental

Arm Title

Glipizide 2.5 mg - 20 mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

MK-0431

Intervention Description

25 mg (one 25-mg tablet) once daily

Intervention Type

Drug

Intervention Name(s)

Glipizide

Other Intervention Name(s)

Glucotrol

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment

Description

Time Frame

Baseline / Week 54

Title

Number of Participants With Clinical Adverse Events

Description

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

Time Frame

54 Week Treatment Period + 28 days

Secondary Outcome Measure Information:

Title

Number of Participants With Symptomatic Hypoglycemic Adverse Events

Description

A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.

Time Frame

54 Week Treatment Period + 28 days

Title

Change From Baseline in Fasting Plasma Glucose (FPG)

Description

Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.

Time Frame

Baseline / Week 54

Title

Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment

Description

Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated.

Time Frame

Baseline / Week 54

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

23352379

Citation

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. Erratum In: Am J Kidney Dis. 2013 Oct;62(4):847.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs