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

This study has been completed.
Sponsor:
Collaborator:
Mackay Memorial Hospital
Information provided by (Responsible Party):
Sung-Chen Liu, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01195090
First received: September 2, 2010
Last updated: September 9, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: Sitagliptin
Drug: pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • Mean Change in Glycosylated Hemoglobin (A1C) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    A1C change from baseline to 24 weeks

  • Baseline A1C [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    baseline A1C

  • The Percentages of Patient Achieving an A1C <7% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The percentages of patient achieving an A1C <7% at endpoint


Secondary Outcome Measures:
  • Changes in Fasting Plasma Glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    fasting serum sugar change from baseline to 24 weeks

  • Changes in High Sensitive C-reactive Protein [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    fasting high sensitive serum C-reactive protein change from baseline to 24 weeks

  • Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    HOMA-IR change from baseline to 24 weeks

  • Body Weight Change [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    body weight change from baseline to 24 weeks

  • Percentages of Patients With Total Adverse Events (AE) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    percentages of total adverse events

  • Change in Fasting Total-cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Total-cholesterol change from baseline to 24 weeks

  • Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    LDL-C change from baseline to 24 weeks

  • Change in Fasting Triglycerides(TG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    TG change from baseline to 24 weeks

  • Change in Fasting High-density Lipoprotein Cholesterol(HDL-C) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    HDL-C change from baseline to 24 weeks

  • Change in Fasting Plasma Alanine-aminotransferase (ALT) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    ALT change from baseline to 24 weeks

  • Percentages of Patients With Mild to Moderate Hypoglycemia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Incidence of mild to moderate hypoglycemia after treatment

  • Percentages of Patients With Edema [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    proportion of edema after treatment

  • Percentages of Patients With Gastrointestinal Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Proportion of Gastrointestinal adverse events after treatment

  • Percentages of Patients With Nasopharyngitis [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Proportion of Nasopharyngitis after treatment

  • Percentages of Patients With Severe Hypoglycemia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Proportion of severe hypoglycemia after treatment

  • Baseline Fasting Plasma Glucose [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Baseline fasting plasma glucose

  • Baseline High Sensitive C-reactive Protein [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Baseline high sensitive C-reactive Protein

  • Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline HOMA-IR ] [ Designated as safety issue: No ]
    Baseline HOMA-IR

  • Baseline Alanine-aminotransferase (ALT) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Baseline alanine-aminotransferase

  • Baseline Body Weight [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Baseline body weight

  • Baseline Total Cholesterol [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline Total cholesterol

  • Baseline Triglyceride (TG) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline TG

  • Baseline Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline LDL-C

  • Baseline High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline HDL-C


Enrollment: 120
Study Start Date: October 2009
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sung-Chen Liu, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01195090     History of Changes
Other Study ID Numbers: 09MMHIS047
Study First Received: September 2, 2010
Results First Received: April 18, 2012
Last Updated: September 9, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by 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
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014