An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

NCT01357135 | Completed Results

• 1 other identifier: 0431-201
• Study Type: observational
• Target: 3,453
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational study to compare the effectiveness of dual therapy of Type II diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in France.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Median Duration (in Months) of Initial Dual Therapy

  The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.

  Up to 3 years

• Percentage of Participants With Strict Changes in Initial Dual Therapy

  Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.

  Up to 3 years

Study Arms (3)

Metformin + Sitagliptin

Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.

Drug: Metformin; Drug: Sitagliptin

Metformin + Sulfonylurea

Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.

Drug: Metformin; Drug: Sulfonylurea

Sitagliptin +/- Other Antihyperglycemic Medication

Participants taking sitagliptin +/- other antihyperglycemic medication (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.

Drug: Antihyperglycemic Medication

Interventions

Metformin DRUG

Metformin + Sitagliptin; Metformin + Sulfonylurea

Sitagliptin DRUG

Metformin + Sitagliptin

Sulfonylurea DRUG

Metformin + Sulfonylurea

Antihyperglycemic Medication DRUG

Sitagliptin +/- Other Antihyperglycemic Medication

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with type II diabetes mellitus receiving a de novo prescription (for the first time or within less than 8 weeks) for dual therapy with or without Januvia®/Xelevia® or any other treatment regimen including Januvia®/Xelevia® by general practitioners in private practice under real life conditions without any additional treatment or monitoring procedures.

You may qualify if:

• Type 2 diabetes participants
• De novo treatment (first prescription or dated within the past 8 weeks) with:
• Metformin + sitagliptin dual therapy,
• Metformin + sulfonylurea dual therapy,
• Sitagliptin as part of another treatment regimen
• Participants also eligible for treatment with sitagliptin (Januvia®/Xelevia®) or a sulfonylurea.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Valensi P, de Pouvourville G, Benard N, Chanut-Vogel C, Kempf C, Eymard E, Moisan C, Dallongeville J. Treatment maintenance duration of dual therapy with metformin and sitagliptin in type 2 diabetes: The ODYSSEE observational study. Diabetes Metab. 2015 Jun;41(3):231-8. doi: 10.1016/j.diabet.2015.03.007. Epub 2015 May 12.

  PMID: 25976701 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Sitagliptin Phosphate; Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Urea; Amides; Sulfones; Sulfur Compounds

Limitations and Caveats

The adverse events in this study were not systematically collected or assessed and therefore no direct comparison can be made between adverse events in the 3 study groups/arms.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: July 15, 2009
• Primary Completion: August 31, 2013
• Study Completion: August 31, 2013
• Last Updated: June 5, 2017
• Results First Posted: December 5, 2014

Record last verified: 2017-05