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

Type 2 Diabetes Clinical Trial

— JAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195090
• Other study ID #: 09MMHIS047
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2010
• Last updated: September 9, 2012
• Start date: October 2009
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin
add sitagliptin100mg/d to pre-study OADs
• pioglitazone
add pioglitazone 30mg/d to pre-study OADs

Locations

Country	Name	City	State
Taiwan	Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Sung-Chen Liu	Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Glycosylated Hemoglobin (A1C)	A1C change from baseline to 24 weeks	24 weeks	Yes
Primary	Baseline A1C	baseline A1C	Baseline	No
Primary	The Percentages of Patient Achieving an A1C <7%	The percentages of patient achieving an A1C <7% at endpoint	24 weeks	No
Secondary	Changes in Fasting Plasma Glucose	fasting serum sugar change from baseline to 24 weeks	24 weeks	Yes
Secondary	Changes in High Sensitive C-reactive Protein	fasting high sensitive serum C-reactive protein change from baseline to 24 weeks	24 weeks	No
Secondary	Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)	HOMA-IR change from baseline to 24 weeks	24 weeks	No
Secondary	Body Weight Change	body weight change from baseline to 24 weeks	24 weeks	Yes
Secondary	Percentages of Patients With Total Adverse Events (AE)	percentages of total adverse events	24 weeks	Yes
Secondary	Change in Fasting Total-cholesterol	Total-cholesterol change from baseline to 24 weeks	24 weeks	No
Secondary	Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)	LDL-C change from baseline to 24 weeks	24 weeks	No
Secondary	Change in Fasting Triglycerides(TG)	TG change from baseline to 24 weeks	24 weeks	No
Secondary	Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)	HDL-C change from baseline to 24 weeks	24 weeks	No
Secondary	Change in Fasting Plasma Alanine-aminotransferase (ALT)	ALT change from baseline to 24 weeks	24 weeks	Yes
Secondary	Percentages of Patients With Mild to Moderate Hypoglycemia	Incidence of mild to moderate hypoglycemia after treatment	24 weeks	Yes
Secondary	Percentages of Patients With Edema	proportion of edema after treatment	24 weeks	Yes
Secondary	Percentages of Patients With Gastrointestinal Adverse Events	Proportion of Gastrointestinal adverse events after treatment	24 weeks	Yes
Secondary	Percentages of Patients With Nasopharyngitis	Proportion of Nasopharyngitis after treatment	24 weeks	Yes
Secondary	Percentages of Patients With Severe Hypoglycemia	Proportion of severe hypoglycemia after treatment	24 weeks	Yes
Secondary	Baseline Fasting Plasma Glucose	Baseline fasting plasma glucose	baseline	No
Secondary	Baseline High Sensitive C-reactive Protein	Baseline high sensitive C-reactive Protein	baseline	No
Secondary	Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)	Baseline HOMA-IR	Baseline HOMA-IR	No
Secondary	Baseline Alanine-aminotransferase (ALT)	Baseline alanine-aminotransferase	Baseline	Yes
Secondary	Baseline Body Weight	Baseline body weight	Baseline	Yes
Secondary	Baseline Total Cholesterol	Baseline Total cholesterol	Baseline	No
Secondary	Baseline Triglyceride (TG)	Baseline TG	Baseline	No
Secondary	Baseline Low-density Lipoprotein Cholesterol (LDL-C)	Baseline LDL-C	Baseline	No
Secondary	Baseline High-density Lipoprotein Cholesterol (HDL-C)	Baseline HDL-C	Baseline	No