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

• ClinicalTrials.gov Identifier: NCT01195090
• Recruitment Status: Completed
• First Posted: September 3, 2010
• Results First Posted: October 10, 2012
• Last Update Posted: October 10, 2012
• Sponsor: Sung-Chen Liu
• Collaborator: Mackay Memorial Hospital
• Information provided by (Responsible Party): Sung-Chen Liu, Mackay Memorial Hospital

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Drug: Sitagliptin; Drug: pioglitazone	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: October 2009
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
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; add pioglitazone 30mg/d to pre-study OADs	Drug: pioglitazone; add pioglitazone 30mg/d to pre-study OADs; Other Name: actos

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Glycosylated Hemoglobin (A1C) [ Time Frame: 24 weeks ]
   A1C change from baseline to 24 weeks
2. Baseline A1C [ Time Frame: Baseline ]
   baseline A1C
3. The Percentages of Patient Achieving an A1C <7% [ Time Frame: 24 weeks ]
   The percentages of patient achieving an A1C <7% at endpoint

Secondary Outcome Measures :

1. Changes in Fasting Plasma Glucose [ Time Frame: 24 weeks ]
   fasting serum sugar change from baseline to 24 weeks
2. Changes in High Sensitive C-reactive Protein [ Time Frame: 24 weeks ]
   fasting high sensitive serum C-reactive protein change from baseline to 24 weeks
3. Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: 24 weeks ]
   HOMA-IR change from baseline to 24 weeks
4. Body Weight Change [ Time Frame: 24 weeks ]
   body weight change from baseline to 24 weeks
5. Percentages of Patients With Total Adverse Events (AE) [ Time Frame: 24 weeks ]
   percentages of total adverse events
6. Change in Fasting Total-cholesterol [ Time Frame: 24 weeks ]
   Total-cholesterol change from baseline to 24 weeks
7. Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 24 weeks ]
   LDL-C change from baseline to 24 weeks
8. Change in Fasting Triglycerides(TG) [ Time Frame: 24 weeks ]
   TG change from baseline to 24 weeks
9. Change in Fasting High-density Lipoprotein Cholesterol(HDL-C) [ Time Frame: 24 weeks ]
   HDL-C change from baseline to 24 weeks
10. Change in Fasting Plasma Alanine-aminotransferase (ALT) [ Time Frame: 24 weeks ]
    ALT change from baseline to 24 weeks
11. Percentages of Patients With Mild to Moderate Hypoglycemia [ Time Frame: 24 weeks ]
    Incidence of mild to moderate hypoglycemia after treatment
12. Percentages of Patients With Edema [ Time Frame: 24 weeks ]
    proportion of edema after treatment
13. Percentages of Patients With Gastrointestinal Adverse Events [ Time Frame: 24 weeks ]
    Proportion of Gastrointestinal adverse events after treatment
14. Percentages of Patients With Nasopharyngitis [ Time Frame: 24 weeks ]
    Proportion of Nasopharyngitis after treatment
15. Percentages of Patients With Severe Hypoglycemia [ Time Frame: 24 weeks ]
    Proportion of severe hypoglycemia after treatment
16. Baseline Fasting Plasma Glucose [ Time Frame: baseline ]
    Baseline fasting plasma glucose
17. Baseline High Sensitive C-reactive Protein [ Time Frame: baseline ]
    Baseline high sensitive C-reactive Protein
18. Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline HOMA-IR ]
    Baseline HOMA-IR
19. Baseline Alanine-aminotransferase (ALT) [ Time Frame: Baseline ]
    Baseline alanine-aminotransferase
20. Baseline Body Weight [ Time Frame: Baseline ]
    Baseline body weight
21. Baseline Total Cholesterol [ Time Frame: Baseline ]
    Baseline Total cholesterol
22. Baseline Triglyceride (TG) [ Time Frame: Baseline ]
    Baseline TG
23. Baseline Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline ]
    Baseline LDL-C
24. Baseline High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline ]
    Baseline HDL-C

Eligibility Criteria

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

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

Contacts and Locations

Locations

Taiwan

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

Taipei, Taiwan, 10449

Sponsors and Collaborators

Sung-Chen Liu

Mackay Memorial Hospital

Investigators

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

More Information

• Responsible Party: Sung-Chen Liu, Mackay Memorial Hospital
• ClinicalTrials.gov Identifier: NCT01195090
• Other Study ID Numbers: 09MMHIS047
• First Posted: September 3, 2010
• Results First Posted: October 10, 2012
• Last Update Posted: October 10, 2012
• Last Verified: September 2012

Keywords provided by Sung-Chen Liu, 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 Phosphate; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action