search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Sitagliptin
pioglitazone
Sponsored by
Sung-Chen Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring sitagliptin, pioglitazone, type 2 diabetes

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sitagliptin

pioglitazone

Arm Description

add sitagliptin100mg/d to pre-study OADs

add pioglitazone 30mg/d to pre-study OADs

Outcomes

Primary Outcome Measures

Mean Change in Glycosylated Hemoglobin (A1C)
A1C change from baseline to 24 weeks
Baseline A1C
baseline A1C
The Percentages of Patient Achieving an A1C <7%
The percentages of patient achieving an A1C <7% at endpoint

Secondary Outcome Measures

Changes in Fasting Plasma Glucose
fasting serum sugar change from baseline to 24 weeks
Changes in High Sensitive C-reactive Protein
fasting high sensitive serum C-reactive protein change from baseline to 24 weeks
Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR change from baseline to 24 weeks
Body Weight Change
body weight change from baseline to 24 weeks
Percentages of Patients With Total Adverse Events (AE)
percentages of total adverse events
Change in Fasting Total-cholesterol
Total-cholesterol change from baseline to 24 weeks
Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
LDL-C change from baseline to 24 weeks
Change in Fasting Triglycerides(TG)
TG change from baseline to 24 weeks
Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)
HDL-C change from baseline to 24 weeks
Change in Fasting Plasma Alanine-aminotransferase (ALT)
ALT change from baseline to 24 weeks
Percentages of Patients With Mild to Moderate Hypoglycemia
Incidence of mild to moderate hypoglycemia after treatment
Percentages of Patients With Edema
proportion of edema after treatment
Percentages of Patients With Gastrointestinal Adverse Events
Proportion of Gastrointestinal adverse events after treatment
Percentages of Patients With Nasopharyngitis
Proportion of Nasopharyngitis after treatment
Percentages of Patients With Severe Hypoglycemia
Proportion of severe hypoglycemia after treatment
Baseline Fasting Plasma Glucose
Baseline fasting plasma glucose
Baseline High Sensitive C-reactive Protein
Baseline high sensitive C-reactive Protein
Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Baseline HOMA-IR
Baseline Alanine-aminotransferase (ALT)
Baseline alanine-aminotransferase
Baseline Body Weight
Baseline body weight
Baseline Total Cholesterol
Baseline Total cholesterol
Baseline Triglyceride (TG)
Baseline TG
Baseline Low-density Lipoprotein Cholesterol (LDL-C)
Baseline LDL-C
Baseline High-density Lipoprotein Cholesterol (HDL-C)
Baseline HDL-C

Full Information

First Posted
September 2, 2010
Last Updated
September 9, 2012
Sponsor
Sung-Chen Liu
Collaborators
Mackay Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01195090
Brief Title
Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea
Acronym
JAS
Official Title
Efficacy of Adding Sitagliptin or Pioglitazone to Patients With Type 2 Diabetes Insufficiently Controlled With Metformin and Sulfonylurea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sung-Chen Liu
Collaborators
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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: Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP) 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 Body weight change, proportion of side effects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
sitagliptin, pioglitazone, type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sitagliptin
Arm Type
Active Comparator
Arm Description
add sitagliptin100mg/d to pre-study OADs
Arm Title
pioglitazone
Arm Type
Active Comparator
Arm Description
add pioglitazone 30mg/d to pre-study OADs
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
add sitagliptin100mg/d to pre-study OADs
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
actos
Intervention Description
add pioglitazone 30mg/d to pre-study OADs
Primary Outcome Measure Information:
Title
Mean Change in Glycosylated Hemoglobin (A1C)
Description
A1C change from baseline to 24 weeks
Time Frame
24 weeks
Title
Baseline A1C
Description
baseline A1C
Time Frame
Baseline
Title
The Percentages of Patient Achieving an A1C <7%
Description
The percentages of patient achieving an A1C <7% at endpoint
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes in Fasting Plasma Glucose
Description
fasting serum sugar change from baseline to 24 weeks
Time Frame
24 weeks
Title
Changes in High Sensitive C-reactive Protein
Description
fasting high sensitive serum C-reactive protein change from baseline to 24 weeks
Time Frame
24 weeks
Title
Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Description
HOMA-IR change from baseline to 24 weeks
Time Frame
24 weeks
Title
Body Weight Change
Description
body weight change from baseline to 24 weeks
Time Frame
24 weeks
Title
Percentages of Patients With Total Adverse Events (AE)
Description
percentages of total adverse events
Time Frame
24 weeks
Title
Change in Fasting Total-cholesterol
Description
Total-cholesterol change from baseline to 24 weeks
Time Frame
24 weeks
Title
Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
Description
LDL-C change from baseline to 24 weeks
Time Frame
24 weeks
Title
Change in Fasting Triglycerides(TG)
Description
TG change from baseline to 24 weeks
Time Frame
24 weeks
Title
Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)
Description
HDL-C change from baseline to 24 weeks
Time Frame
24 weeks
Title
Change in Fasting Plasma Alanine-aminotransferase (ALT)
Description
ALT change from baseline to 24 weeks
Time Frame
24 weeks
Title
Percentages of Patients With Mild to Moderate Hypoglycemia
Description
Incidence of mild to moderate hypoglycemia after treatment
Time Frame
24 weeks
Title
Percentages of Patients With Edema
Description
proportion of edema after treatment
Time Frame
24 weeks
Title
Percentages of Patients With Gastrointestinal Adverse Events
Description
Proportion of Gastrointestinal adverse events after treatment
Time Frame
24 weeks
Title
Percentages of Patients With Nasopharyngitis
Description
Proportion of Nasopharyngitis after treatment
Time Frame
24 weeks
Title
Percentages of Patients With Severe Hypoglycemia
Description
Proportion of severe hypoglycemia after treatment
Time Frame
24 weeks
Title
Baseline Fasting Plasma Glucose
Description
Baseline fasting plasma glucose
Time Frame
baseline
Title
Baseline High Sensitive C-reactive Protein
Description
Baseline high sensitive C-reactive Protein
Time Frame
baseline
Title
Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Description
Baseline HOMA-IR
Time Frame
Baseline HOMA-IR
Title
Baseline Alanine-aminotransferase (ALT)
Description
Baseline alanine-aminotransferase
Time Frame
Baseline
Title
Baseline Body Weight
Description
Baseline body weight
Time Frame
Baseline
Title
Baseline Total Cholesterol
Description
Baseline Total cholesterol
Time Frame
Baseline
Title
Baseline Triglyceride (TG)
Description
Baseline TG
Time Frame
Baseline
Title
Baseline Low-density Lipoprotein Cholesterol (LDL-C)
Description
Baseline LDL-C
Time Frame
Baseline
Title
Baseline High-density Lipoprotein Cholesterol (HDL-C)
Description
Baseline HDL-C
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Chen Liu, MD
Organizational Affiliation
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs