Clinical trial NCT01195090: Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea
Official title: Efficacy of Adding Sitagliptin or Pioglitazone to Patients With Type 2 Diabetes Insufficiently Controlled With Metformin and Sulfonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: sitagliptin
pioglitazone
type 2 diabetes
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Mackay Memorial Hospital
First posted: 2010-09-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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

Primary outcomes:
measure: Mean Change in Glycosylated Hemoglobin (A1C)
timeFrame: 24 weeks
measure: Baseline A1C
timeFrame: Baseline
measure: The Percentages of Patient Achieving an A1C <7%
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in Fasting Plasma Glucose
timeFrame: 24 weeks
measure: Changes in High Sensitive C-reactive Protein
timeFrame: 24 weeks
measure: Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: 24 weeks
measure: Body Weight Change
timeFrame: 24 weeks
measure: Percentages of Patients With Total Adverse Events (AE)
timeFrame: 24 weeks
measure: Change in Fasting Total-cholesterol
timeFrame: 24 weeks
measure: Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: 24 weeks
measure: Change in Fasting Triglycerides(TG)
timeFrame: 24 weeks
measure: Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)
timeFrame: 24 weeks
measure: Change in Fasting Plasma Alanine-aminotransferase (ALT)
timeFrame: 24 weeks
measure: Percentages of Patients With Mild to Moderate Hypoglycemia
timeFrame: 24 weeks
measure: Percentages of Patients With Edema
timeFrame: 24 weeks
measure: Percentages of Patients With Gastrointestinal Adverse Events
timeFrame: 24 weeks
measure: Percentages of Patients With Nasopharyngitis
timeFrame: 24 weeks
measure: Percentages of Patients With Severe Hypoglycemia
timeFrame: 24 weeks
measure: Baseline Fasting Plasma Glucose
timeFrame: baseline
measure: Baseline High Sensitive C-reactive Protein
timeFrame: baseline
measure: Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline HOMA-IR
measure: Baseline Alanine-aminotransferase (ALT)
timeFrame: Baseline
measure: Baseline Body Weight
timeFrame: Baseline
measure: Baseline Total Cholesterol
timeFrame: Baseline
measure: Baseline Triglyceride (TG)
timeFrame: Baseline
measure: Baseline Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline
measure: Baseline High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Study officials:
affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
name: Sung-Chen Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: