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A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)

NCT01477853 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2018-07-26

Study results available
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Summary

This two-phase study was to examine if 16 weeks of treatment with sitagliptin in combination with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol (LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively. Following a single-blind placebo run-in period, participants were to be randomized to one of three treatment arms (sitagliptin monotherapy, atorvastatin monotherapy, or sitagliptin plus atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54), participants were to receive either sitagliptin plus atorvastatin or glimepiride plus atorvastatin. The primary hypotheses were that after 16 weeks of treatment, sitagliptin in combination with atorvastatin reduces A1C from baseline more than atorvastatin alone, and that atorvastatin in combination with sitagliptin lowers LDL-C from baseline more than sitagliptin alone.

Conditions

Interventions

DRUG

Sitagliptin

Sitagliptin 100 mg tablet orally daily

DRUG

Atorvastatin

Atorvastatin 80 mg tablet orally daily

OTHER

Placebo to sitagliptin

Placebo to sitagliptin tablet orally daily

OTHER

Placebo to atorvastatin

Placebo to atorvastatin tablet orally daily.

DRUG

Metformin (open-label)

Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study.

DRUG

Glimepiride (open-label)

Phase A: Glimepiride 1 or 2 mg tablet once daily with breakfast or the first main meal of the day (titrated up to 6 mg/day) for 16 weeks as rescue therapy for randomized participants not meeting specific glycemic goals.

DRUG

Glimepiride (double-blind)

Phase B: glimepiride up to 6 mg daily for participants not rescued with open-label glimepiride during Phase A.

DRUG

Placebo to glimepiride

Phase B: placebo to glimepiride tablet orally daily.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-24
Primary Completion
2012-12-04
Completion
2012-12-04

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477853 on ClinicalTrials.gov