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Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea (JAS)

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ClinicalTrials.gov Identifier: NCT01195090
Recruitment Status : Completed
First Posted : September 3, 2010
Results First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin Drug: pioglitazone Phase 4

Detailed Description:

This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria: type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks. > 20 years old; A1C:> 7.0 % and < 11% Exclusion criteria: insulin use within 12 weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) > 2.5 times the upper limit of normal (ULN), current or prepare to pregnancy and lactation.

Primary Purpose:

compare the change in hemoglobin A1c and the proportion of patients achieving A1C < 7% between the 2 groups

Secondary Purposes:

  1. Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP)
  2. Homeostasis model assessment-β cell function(HOMA-β) will be calculated to assess changes in β-cell function and HOMA-insulin resistance(HOMA-IR)to assess changes in insulin resistance
  3. Body weight change, proportion of side effects

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Adding Sitagliptin or Pioglitazone to Patients With Type 2 Diabetes Insufficiently Controlled With Metformin and Sulfonylurea
Study Start Date : October 2009
Primary Completion Date : October 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: sitagliptin
add sitagliptin100mg/d to pre-study OADs
Drug: Sitagliptin
add sitagliptin100mg/d to pre-study OADs
Other Name: Januvia
Active Comparator: pioglitazone
add pioglitazone 30mg/d to pre-study OADs
Drug: pioglitazone
add pioglitazone 30mg/d to pre-study OADs
Other Name: actos


Outcome Measures

Primary Outcome Measures :
  1. Mean Change in Glycosylated Hemoglobin (A1C) [ Time Frame: 24 weeks ]
    A1C change from baseline to 24 weeks

  2. Baseline A1C [ Time Frame: Baseline ]
    baseline A1C

  3. The Percentages of Patient Achieving an A1C <7% [ Time Frame: 24 weeks ]
    The percentages of patient achieving an A1C <7% at endpoint


Secondary Outcome Measures :
  1. Changes in Fasting Plasma Glucose [ Time Frame: 24 weeks ]
    fasting serum sugar change from baseline to 24 weeks

  2. Changes in High Sensitive C-reactive Protein [ Time Frame: 24 weeks ]
    fasting high sensitive serum C-reactive protein change from baseline to 24 weeks

  3. Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: 24 weeks ]
    HOMA-IR change from baseline to 24 weeks

  4. Body Weight Change [ Time Frame: 24 weeks ]
    body weight change from baseline to 24 weeks

  5. Percentages of Patients With Total Adverse Events (AE) [ Time Frame: 24 weeks ]
    percentages of total adverse events

  6. Change in Fasting Total-cholesterol [ Time Frame: 24 weeks ]
    Total-cholesterol change from baseline to 24 weeks

  7. Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 24 weeks ]
    LDL-C change from baseline to 24 weeks

  8. Change in Fasting Triglycerides(TG) [ Time Frame: 24 weeks ]
    TG change from baseline to 24 weeks

  9. Change in Fasting High-density Lipoprotein Cholesterol(HDL-C) [ Time Frame: 24 weeks ]
    HDL-C change from baseline to 24 weeks

  10. Change in Fasting Plasma Alanine-aminotransferase (ALT) [ Time Frame: 24 weeks ]
    ALT change from baseline to 24 weeks

  11. Percentages of Patients With Mild to Moderate Hypoglycemia [ Time Frame: 24 weeks ]
    Incidence of mild to moderate hypoglycemia after treatment

  12. Percentages of Patients With Edema [ Time Frame: 24 weeks ]
    proportion of edema after treatment

  13. Percentages of Patients With Gastrointestinal Adverse Events [ Time Frame: 24 weeks ]
    Proportion of Gastrointestinal adverse events after treatment

  14. Percentages of Patients With Nasopharyngitis [ Time Frame: 24 weeks ]
    Proportion of Nasopharyngitis after treatment

  15. Percentages of Patients With Severe Hypoglycemia [ Time Frame: 24 weeks ]
    Proportion of severe hypoglycemia after treatment

  16. Baseline Fasting Plasma Glucose [ Time Frame: baseline ]
    Baseline fasting plasma glucose

  17. Baseline High Sensitive C-reactive Protein [ Time Frame: baseline ]
    Baseline high sensitive C-reactive Protein

  18. Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline HOMA-IR ]
    Baseline HOMA-IR

  19. Baseline Alanine-aminotransferase (ALT) [ Time Frame: Baseline ]
    Baseline alanine-aminotransferase

  20. Baseline Body Weight [ Time Frame: Baseline ]
    Baseline body weight

  21. Baseline Total Cholesterol [ Time Frame: Baseline ]
    Baseline Total cholesterol

  22. Baseline Triglyceride (TG) [ Time Frame: Baseline ]
    Baseline TG

  23. Baseline Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline ]
    Baseline LDL-C

  24. Baseline High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline ]
    Baseline HDL-C


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks
  • > 20 years old
  • A1C: > 7.0 % and < 11%

Exclusion Criteria:

  • Insulin use within 12 weeks of the screening visit
  • Any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase levels > 2.5 times the upper limit of normal
  • Current or prepare to pregnancy and lactation
Contacts and Locations

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): NCT01195090


Locations
Taiwan
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Taipei, Taiwan, 10449
Sponsors and Collaborators
Sung-Chen Liu
Mackay Memorial Hospital
Investigators
Principal Investigator: Sung-Chen Liu, MD Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
More Information

Responsible Party: Sung-Chen Liu, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01195090     History of Changes
Other Study ID Numbers: 09MMHIS047
First Posted: September 3, 2010    Key Record Dates
Results First Posted: October 10, 2012
Last Update Posted: October 10, 2012
Last Verified: September 2012

Keywords provided by Sung-Chen Liu, Mackay Memorial Hospital:
sitagliptin
pioglitazone
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
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