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Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820573
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Eugenio Cersosimo, The University of Texas Health Science Center at San Antonio

Brief Summary:

In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after 6 weeks of treatment:

Objective: To assess the effects of co-administration of sitagliptin and metformin compared to placebo on hepatic glucose production (HGP).

Hypothesis: After 6 weeks of treatment, the co-administration of sitagliptin and metformin provides greater reduction in hepatic glucose production (HGP) compared to placebo.


Condition or disease Intervention/treatment Phase
Diabetes Drug: Sitagliptin Drug: Metformin Drug: Sitagliptin + Metformin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With Type 2 Diabetes Mellitus
Study Start Date : October 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo to be provided for 6 weeks
Drug: Placebo
Placebo 6 weeks
Other Name: Placebo tablet

Experimental: Sitagliptin
Sitagliptin to be provided for 6 weeks
Drug: Sitagliptin
tablet, 100 mg/day, 6 weeks
Other Name: Januvia

Experimental: Metformin
Metformin to be provided for 6 weeks
Drug: Metformin
tablet, 1000 mg/ bid, 6 weeks
Other Name: Glucophage

Experimental: Sitagliptin+Metfromin
Sitagliptin + Metformin combined will be provided for 6 weeks
Drug: Sitagliptin + Metformin
tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks
Other Name: Januvia and glucophage




Primary Outcome Measures :
  1. Objective: Comparisons of the Effects of Co-administration of Sitagliptin and Metformin Alone or in Combination Versus Placebo on Baseline Endogenous Glucose Production (EGP). [ Time Frame: 6 weeks ]
    Baseline endogenous glucose production prior to a mixed meal tolerance test (placebo) and following 6 weeks of either sitagliptin, metformin or sitagliptin plus metformin combination therapy in all 16 participants

  2. Average of Plasma Glucose During Mixed Meal Tolerance Test (MTT) Compared to Baseline Plasma Glucose to Post Therapy (6-weeks). [ Time Frame: 6 weeks ]
    The degree of suppression of baseline endogenous glucose production was measured in absolute values and as a percent of basal values at the end of each 6-week therapeutic period. The absolute values obtained in each sequence study group (both basal and post-meal) were compared amongst all groups.


Secondary Outcome Measures :
  1. Fasting Plasma Glucose 6 Weeks After Therapy [ Time Frame: 6 weeks ]
    Basal pasma glucose was determined with the glucose oxidase method after each specific 6 week treatment. The absolute values obtained of basal plasma glucose at the end of each 6-week therapeutic period in each sequence study group (both basal and post-meal) were compared amongst all groups.

  2. Changes in Plasma Glucose Post-MTT After Each Six Weeks of Therapy Compared to Baseline [ Time Frame: 360 min ]
    The absolute values of mean plasma glucose post-meal (360 minutes)were determined after each specific 6 week treatment and these absolute values after each specific sequence therapy were compared amongst all groups.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must meet all of the following inclusion criteria to participate in the study.
  • Patients with screening values/findings outside ranges described in the protocol may have one repeat determination performed and if the repeat value satisfies the criterion, they may continue in the screening process.
  • If the repeat value does not satisfy the criterion, the principal investigator will review the abnormal laboratory value and decide whether the subject may continue in the screening process.
  • All screening laboratory measurements are to be performed after an overnight fast ≥10 hours in duration.
  • Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  • Patients can be either male or female.
  • Patients are ≥18 and ≤70 years of age on the day of signing informed consent.
  • Patients must meet the current American Diabetes Association criteria for the diagnosis of type 2 diabetes mellitus
  • Patients must be on diet or diet plus exercise therapy.
  • Patients must have a HbA1c ≥ 7.5% and ≤ 9.5%
  • Patients must have a BMI of 23-40 kg/m2
  • Patients must have the following laboratory values:

    • Hematocrit Males ≥ 34 vol%
    • Females ≥ 33vol%
    • Serum creatinine ≤ 1.5 mg/dL in males and ≤ 1.4 mg/dL in females
    • AST (SGOT): ≤ 2.5 times upper limit of normal
    • ALT (SGPT): ≤ 2.5 times upper limit of normal
    • Alkaline phosphatase ≤ 2.5 times upper limit of normal
    • If serum creatinine is > 1.5 mg/dl in males and > 1.4 mg/dl in females, the Principal Investigator can include the patient if the measured GFR is >70 ml/min (24 hour creatinine clearance)
  • Patients must have been on a stable dose of allowed chronic medications for ≥30 days prior to entering the study.
  • Only patients whose body weight has been stable (±4 pounds) over the three months prior to the study will be included.

Exclusion Criteria:

  • Patients are excluded from participation in the study if they meet any of the following criteria:

    • Patient has type 1 diabetes.
    • Patient has received insulin for more than one week within the previous year prior to entry.
    • Patient has been treated with exenatide or a non-TZD, oral antihyperglycemic agent within the last 2 months or with a TZD (pioglitazone or rosiglitazone) within the last 4 months.
    • Patient is receiving any medications with known adverse effects on glucose tolerance (e.g., systemic glucocorticoids, psychotropic drugs like clozapine, olanzapine, haloperidol, risperidone). Note: Patients may be taking stable doses of estrogens, other hormonal replacement therapy, or lipid and blood pressure lowering agents if the patient has been on these agents for the prior three months.
    • Patient has evidence of a significant cardiovascular disorder within 6 months of signing informed consent (e.g. acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder) or has New York Heart Association Classification greater than Class 2; or has significant findings on ECG (other than non-specific ST-T wave changes); or peripheral vascular disease (history of claudication); or has dyspnea on exertion of one flight or less, or abnormal breath sounds on auscultation.
    • Patient has a history of intolerance or hypersensitivity to a DPP-4 inhibitor or to metformin.
    • Patient is pregnant or plans to become pregnant within the projected duration of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820573


Locations
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United States, Texas
Texas Diabetes Institute
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Eugenio Cersosimo, MD University of TX Health Science Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eugenio Cersosimo, Associate Professor Medicine, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00820573    
Other Study ID Numbers: 35464
First Posted: January 12, 2009    Key Record Dates
Results First Posted: December 13, 2013
Last Update Posted: December 13, 2013
Last Verified: December 2013
Keywords provided by Eugenio Cersosimo, The University of Texas Health Science Center at San Antonio:
Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action