Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients

NCT02099838 | Completed Phase 4 Results DMC

• 1 other identifier: Tongji201202
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Pioglitazone; Metformin; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change of HbA1c From Baseline at Week 12

  Measuring venous level of HbA1c at the start of the trail and at week 12 in all subjects, then using the natural logarithm of HbA1c to analyze the change in HbA1c from baseline at week 12 and compare that between experiment group and control group, since the HbA1c wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).

  Baseline, Week 12

Secondary Outcomes (8)

• Change of FPG From Baseline at Week 12

  Baseline, Week 12

• Change of 2hPPG From Baseline at Week 12

  Baseline, Week 12

• Change of Fasting Insulin From Baseline at Week 12

  Baseline, Week 12

• Change of 2-hour Postprandial Insulin From Baseline at Week 12

  Baseline, Week 12

• Change of TC From Baseline at Week 12

  Baseline, Week 12

Other Outcomes (4)

• Change of ALT From Baseline at Week 12

  Baseline, Week 12

• Change of AST From Baseline at Week 12

  Baseline, Week 12

• Change of TBil From Baseline at Week 12

  Baseline, Week 12

Study Arms (2)

Pioglitazone and Metformin

EXPERIMENTAL

Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.

Drug: Pioglitazone and Metformin

Placebo

PLACEBO COMPARATOR

Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.

Drug: Placebo

Interventions

Pioglitazone and Metformin DRUG

taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks

Also known as: Compound Preparation of Pioglitazone and Metformin, Kashuangping, H20100180

Pioglitazone and Metformin

Placebo DRUG

taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients (WHO criterion, 1999)
• kg/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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Wuhan Iron and Steel Workers' Hospital: collaborator
• Wuhan Pu-Ai Hospital: collaborator
• Hubei Xinhua Hospital: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Dr. Yu
• Organization: Huazhong University of Science and Technology

xfyu188@163.com

027-83662883

Study Officials

• Xuefeng Yu, MD, PhD

  Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Endocrinology

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 31, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 25, 2014
• Results First Posted: June 10, 2014

Record last verified: 2014-06

Locations

CN (1)