Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea (JAS)
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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 |
- 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
- 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
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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:
- 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
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Taiwan | |
| Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital | |
| Taipei, Taiwan, 10449 | |
| 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 May 19, 2013