Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

NCT01340768 | Completed Phase 3 Results

• 2 other identifiers: 0431-262CTRI/2011/06/001838
• Study Type: interventional
• Target: 870
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.

Conditions

Type 2 Diabetes Mellitus

Keywords

Glucose metabolism disorders Metabolic diseases Peptidase inhibitors

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least One Symptomatic Hypoglycemic Event

  Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).

  Up to 30 days (Day 1 through last day of Ramadan)

Secondary Outcomes (1)

• Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event

  Up to 30 days (Day 1 through last day of Ramadan)

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Sitagliptin 100mg taken orally once daily with or without metformin

Drug: Sitagliptin; Drug: Metformin

Sulfonylurea Therapy

ACTIVE COMPARATOR

Usual sulfonylurea therapy with or without metformin

Drug: Sulfonylurea; Drug: Metformin

Interventions

Sitagliptin DRUG

One 100 mg tablet taken orally once daily

Also known as: Sitagliptin phosphate, MK-0431, JANUVIA®

Sitagliptin

Sulfonylurea DRUG

Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.

Also known as: Amaryl (glimepiride)

Sulfonylurea Therapy

Metformin DRUG

Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.

Also known as: Glucophage

Sitagliptin; Sulfonylurea Therapy

Eligibility Criteria

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

You may qualify if:

• Muslim, with type 2 diabetes mellitus
• Intends to fast during the month of Ramadan
• Hemoglobin A1c (HbA1c) ≤10% at screening
• On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose

You may not qualify if:

• Type 1 diabetes mellitus
• Pregnant or breast feeding or with gestational diabetes
• Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
• Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
• History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)
• Any use of insulin (prior to or during Ramadan)
• Use of any class of oral antidiabetic therapy other than an SU or metformin
• Current participation in another interventional study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.

  PMID: 37435938 DERIVED

• Aravind SR, Ismail SB, Balamurugan R, Gupta JB, Wadhwa T, Loh SM, Suryawanshi S, Davies MJ, Girman CJ, Katzeff HL, Radican L, Engel SS, Wolthers T. Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study. Curr Med Res Opin. 2012 Aug;28(8):1289-96. doi: 10.1185/03007995.2012.707119. Epub 2012 Jul 6.

  PMID: 22738801 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Sulfonylurea Compounds; glimepiride; 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; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: April 25, 2011
• Study Start: June 22, 2010
• Primary Completion: September 21, 2011
• Study Completion: September 21, 2011
• Last Updated: June 5, 2017
• Results First Posted: October 8, 2012

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share