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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014