Phase 4
Completed N=120
Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea
Source: ClinicalTrials.gov NCT01195090 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Mean Change in Glycosylated Hemoglobin (A1C) — -0.71; -0.94 percentage of Hb — p=0.165
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Glycosylated Hemoglobin (A1C) |
-0.71; -0.94 | 0.165 |
| PRIMARY Baseline A1C |
8.27; 8.54 | — |
| PRIMARY The Percentages of Patient Achieving an A1C <7% |
28.3; 28.8 | 0.954 |
| SECONDARY Changes in Fasting Plasma Glucose |
-23; -36 | — |
| SECONDARY Changes in High Sensitive C-reactive Protein |
-0.07; -0.19 | — |
| SECONDARY Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) |
-0.00; -1.56 | — |
| SECONDARY Body Weight Change |
-0.26; 1.34 | — |
| SECONDARY Percentages of Patients With Total Adverse Events (AE) |
43.1; 51.7 | — |
| SECONDARY Change in Fasting Total-cholesterol |
0.6; 9.9 | — |
| SECONDARY Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C) |
-1.2; 6.6 | — |
| SECONDARY Change in Fasting Triglycerides(TG) |
6.3; -23.9 | — |
| SECONDARY Change in Fasting High-density Lipoprotein Cholesterol(HDL-C) |
1.3; 6.3 | — |
| SECONDARY Change in Fasting Plasma Alanine-aminotransferase (ALT) |
-0.0; -4.5 | — |
| SECONDARY Percentages of Patients With Mild to Moderate Hypoglycemia |
10; 8.5 | — |
| SECONDARY Percentages of Patients With Edema |
0; 27.1 | — |
| SECONDARY Percentages of Patients With Gastrointestinal Adverse Events |
20.0; 6.8 | — |
| SECONDARY Percentages of Patients With Nasopharyngitis |
20.0; 18.6 | — |
| SECONDARY Percentages of Patients With Severe Hypoglycemia |
0; 0 | — |
| SECONDARY Baseline Fasting Plasma Glucose |
177; 182 | — |
| SECONDARY Baseline High Sensitive C-reactive Protein |
0.38; 0.42 | — |
| SECONDARY Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) |
5.6; 4.8 | — |
| SECONDARY Baseline Alanine-aminotransferase (ALT) |
34.2; 28.5 | — |
| SECONDARY Baseline Body Weight |
69.4; 65.4 | — |
| SECONDARY Baseline Total Cholesterol |
174; 194 | — |
| SECONDARY Baseline Triglyceride (TG) |
137; 164 | — |
| SECONDARY Baseline Low-density Lipoprotein Cholesterol (LDL-C) |
102; 111 | — |
| SECONDARY Baseline High-density Lipoprotein Cholesterol (HDL-C) |
42; 43 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01195090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.