Phase 4
N=98
Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02099838 ↗Enrolled (actual)
98
Serious AEs
1.0%
Results posted
Jun 2014
Primary outcome: Primary: Change of HbA1c From Baseline at Week 12 — 2.14; 2.10; 1.95; 2.02 ln(percent) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pioglitazone and Metformin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Huazhong University of Science and Technology
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of HbA1c From Baseline at Week 12 |
2.14; 2.10; 1.95; 2.02; 0.19; 0.07 | <0.0001 sig |
| SECONDARY Change of FPG From Baseline at Week 12 |
2.16; 2.08; 1.91; 2.05; 0.25; 0.04 | <0.0001 sig |
| SECONDARY Change of 2hPPG From Baseline at Week 12 |
16.47; 15.59; 12.68; 15.23; 3.65; 0.45 | <0.0001 sig |
| SECONDARY Change of Fasting Insulin From Baseline at Week 12 |
2.21; 2.17; 1.90; 2.26; 0.35; -0.08 | <0.0001 sig |
| SECONDARY Change of 2-hour Postprandial Insulin From Baseline at Week 12 |
3.49; 3.48; 3.33; 3.64; 0.19; -0.15 | 0.1147 |
| SECONDARY Change of TC From Baseline at Week 12 |
4.76; 4.76; 4.74; 4.66; 0.06; 0.09 | 0.3795 |
| SECONDARY Change of TG From Baseline at Week 12 |
1.76; 1.71; 1.66; 1.85; 0.09; -0.17 | 0.3151 |
| SECONDARY Change of HDL From Baseline at Week 12 |
1.22; 1.13; 1.33; 1.15; -0.09; 0.00 | 0.0038 sig |
| SECONDARY Change of LDL From Baseline at Week 12 |
0.90; 0.87; 0.89; 0.83; 0.02; 0.03 | 0.5476 |
Summary
Secondary failure of sulfonylureas (SUs) can occur in about 30%-40% of type 2 diabetic patients after treatment with SUs for 5 years, although SUs are widely used in type 2 diabetic patients. This study was designed to evaluate the effectiveness and safety of adding compound preparation of pioglitazone and metformin for type 2 diabetic patients who have bad glycemic control with the initial treatment of SUs.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetic patients (WHO criterion, 1999)
- 19kg/m2 ≤ BMI ≤ 35kg/m2
- Subject with the initial treatment of SUs on the basis of controlling diet and sport; treatment lasting for no less than 3 months and stable dose for at least 1 month; HbA1c 7-11%
- No insulin therapy during 6 months before being selected
- Not involved in any drug test during 3 months before being selected
- No serious heart, liver or kidney diseases
- Must have effective contraception methods for women of child-bearing age
- Willing to being informed consent
Exclusion Criteria
- Type 1 diabetes or other specific types of diabetes
- Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods
- Uncooperative subject because of various reasons
- Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) > twice the upper limits of normal
- Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male
- Serious chronic gastrointestinal diseases
- Edema
- Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
- Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
- White blood count (WBC) < 4.0×109/L or platelet count (PLT) < 90×109/L，or definite anemia (Hb：< 120g/L for male, < 110g/L for female), or other hematological diseases
- Endocrine system diseases, such as hyperthyroidism and hypercortisolism
- Experimental drug allergy or frequent hypoglycemia
- Psychiatric disorders, drug or other substance abuse
- Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
- Stressful situations such as surgery, serious trauma and so on
- Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease
- Combined use of drugs effecting glucose metabolism such as glucocorticoid
- Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria
Data sourced from ClinicalTrials.gov (NCT02099838). 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.