Impacts of PIO/MET Following Short-term Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes

NCT03196362 | Unknown Phase 4 DMC

• 1 other identifier: 20160145
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Short-term intensive insulin therapy (SIIT) induces glycemic remission in patients with newly diagnosed type 2 diabetes. But remission rate reduces over time. This study aims to investigate whether sequential treatments using fixed dose combination of pioglitazone/metformin (15mg/500mg) after SIIT can improve clinical outcomes inpatients with newly diagnosed type 2 diabetes. We plan to include 50 patients with newly diagnosed type 2 diabetes who are drug naïve and meet the inclusive criteria will be enrolled. After baseline assessments, SIIT will be applied to all patients using insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Patients were randomly assigned into either of the following two groups: PIO/MET group: pioglitazone/metformin (15mg/500mg) will be orally administrated twice daily to the subjects for 12 weeks; placebo group: placebo is given twice daily to all subjects for 12 weeks. Afterwards, patients will be followed up for 48 weeks. Primary endpoint is difference in remission rate at the end of study. Secondary endpoints include proportion of patients who achieve glycosylated hemoglobin A1C \<7% at the end of study; differences in β-cell function , insulin sensitivity and incidence of adverse events among treatment groups.

Conditions

Type 2 Diabetes Mellitus

Keywords

short-term intensive insulin therapy; pioglitazone; metformin; remission; sequential therapy

Outcome Measures

Primary Outcomes (1)

• Remission rate

  Remission rate at the end of the study in each group

  48 weeks

Secondary Outcomes (4)

• β-cell function

  48 weeks

• Insulin sensitivity

  48 weeks

• glycemic control

  48 weeks

• Adverse events

  48 weeks

Study Arms (2)

PIO/MET

ACTIVE COMPARATOR

one fixed dose pioglitazone/metformin (15mg/500mg) tablet will be orally administrated twice daily

Drug: Pioglitazone + Metformin

placebo

PLACEBO COMPARATOR

one tablet of placebo will be given twice daily

Drug: Placebo Oral Tablet

Interventions

Pioglitazone + Metformin DRUG

One tablet of fixed dose of Pioglitazone/ Metformin (15mg/30mg) will be given twice daily

PIO/MET

Placebo Oral Tablet DRUG

One tablet of placebo will be given twice daily

placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed type 2 diabetes who have never received any hypoglycemic treatment;
• Fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl); glycosylated hemoglobin A1C\>8.5%;
• Aged between 25 and 65 years,
• Body mass index (BMI) 22-35 kg/m2.

You may not qualify if:

• Type 1 diabetes or special type of diabetes;
• Acute diabetic complications of diabetes (DKA, HHS and lactic acidosis etc.)
• Serious microvascular complications: proliferative stage of retinopathy; urine AER \>300 mg/g or urine protein positive, quantification \>0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
• Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment;
• Persistently increased blood pressure \>180/110 mmHg;
• Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal;
• Hemoglobin \<100 g/L or need regular blood transfusion;
• Use of drugs that may influence blood glucose within 12 weeks;
• Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea;
• Uncontrolled endocrine gland dysfunction;
• Patients with mental or communication disorders;
• Chronic cardiac insufficiency, heart function class III and above;
• Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study;
• Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

endocrinology department of the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

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

Central Study Contacts

Liehua Liu, PHD

CONTACT

+8613751748843; turkey310@163.com

Study Design

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

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: December 1, 2016
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2018
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)