Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296412
• Other study ID #: 0431-403
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2011
• Last updated: February 23, 2015
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based

treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 653
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion criteria

• Type 2 diabetes mellitus.

• On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C =7.0% and =11.0%.

• Capable of using a liraglutide pen device.

Exclusion criteria

• History of Type 1 Diabetes mellitus.

• Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening.

• Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder.

• Impaired liver function.

• Impaired kidney function.

• History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study.

• History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment.

• Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study.

• Participation in another study with an investigational drug or device within 12 weeks prior to screening.

• History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site.

• Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks.

• Surgery within the prior 4 weeks or major surgery planned during the study.

• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

• User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• sitagliptin
100 mg tablet, orally, once daily.
• liraglutide
0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals.
• glimepiride
starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.
• metformin
metformin tablets at a dose of =1500 mg per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (A1C)	A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.	Baseline and Week 26	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)	Change from baseline at Week 26 is defined as Week 26 minus Week 0.	Baseline and Week 26	No
Secondary	Percentage of Participants Reaching A1C Goal of <7.0%		Week 26	No
Secondary	Percentage of Participants Reaching A1C Goal of <6.5%		Week 26	No