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

Efficacy of Adding Sitagliptin or Pioglitazone to Patients With Type 2 Diabetes Insufficiently Controlled With Metformin and Sulfonylurea

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Sitagliptin; Drug: pioglitazone

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10449
    • Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sitagliptin; add sitagliptin100mg/d to pre-study OADs	Drug: Sitagliptin; add sitagliptin100mg/d to pre-study OADs; Other Names: Januvia
Active Comparator: pioglitazone; add pioglitazone 30mg/d to pre-study OADs	Drug: pioglitazone; add pioglitazone 30mg/d to pre-study OADs; Other Names: actos

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sung-Chen Liu
• Collaborators: Mackay Memorial Hospital
• Investigators: Principal Investigator: Sung-Chen Liu, MD, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 2, 2010
• First Posted (Estimate): September 3, 2010

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: September 9, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: type 2 diabetes; pioglitazone; sitagliptin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Pioglitazone; Sitagliptin Phosphate
• Other Study ID Numbers: 09MMHIS047