Sitagliptin in Combination With Metformin and Sulfonylurea
This study has been completed.
Sponsor:
Charles Drew University of Medicine and Science
Collaborator:
Information provided by:
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00686634
First received: May 27, 2008
Last updated: September 15, 2010
Last verified: September 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Sitagliptin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Charles Drew University of Medicine and Science:
Primary Outcome Measures:
- Hemoglobin A1c change from baseline [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects with hemoglobin A1c 7.5% or less [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Proportion of subjects maintaining hemoglobin A1c 7.5% or less [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Any adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 108 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Sitagliptin 100 mg once daily
|
Drug: Sitagliptin
Sitagliptin 100 mg po once daily
Other Name: Trade name: Januvia
|
Detailed Description:
The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, age 18-75
- Type 2 diabetes
- At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (HbA1c >7.0%)
- Able to comply with all scheduled visits and requirements of the protocol
Exclusion Criteria:
- Any contraindications to the use of metformin or a sulfonylurea agent
- Extreme hyperglycemia or symptoms of polyuria or polydipsia
- Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
- History of confirmed (or clinical suspicion of) type 1 diabetes mellitus
- Episodes of symptomatic hypoglycemia averaging greater than once per day
- Estimated GFR (MDRD) < 60 mL/min
- Subjects with active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c unreliable
- History of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
- Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
- Current pregnancy or lactation.
- Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
- Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
- Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686634
Locations
| United States, California | |
| Charles Drew University of Medicine and Science | |
| Los Angeles, California, United States, 90059 | |
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Investigators
| Principal Investigator: | Stanley Hsia, MD | Charles Drew University of Medicine and Science |
More Information
No publications provided by Charles Drew University of Medicine and Science
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stanley Hsia, MD, Charles Drew University of Medicine and Science |
| ClinicalTrials.gov Identifier: | NCT00686634 History of Changes |
| Other Study ID Numbers: | 07-06-002, U54RR014616 |
| Study First Received: | May 27, 2008 |
| Last Updated: | September 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Charles Drew University of Medicine and Science:
|
sitagliptin type 2 diabetes combination therapy |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013