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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Pioglitazone + Metformin

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring short-term intensive insulin therapy, pioglitazone, metformin, remission, sequential therapy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PIO/MET

placebo

Arm Description

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

one tablet of placebo will be given twice daily

Outcomes

Primary Outcome Measures

Remission rate

Remission rate at the end of the study in each group

Secondary Outcome Measures

β-cell function

Difference in β-cell secretion capacity at the end of follow up between treatment groups

Insulin sensitivity

Difference in insulin sensitivity at the end of follow up between treatment groups

glycemic control

proportion of patients who achieve A1C<7% at the end of follow-up

Adverse events

difference in AEs at the end of follow-up between treatment groups

Full Information

NCT ID

NCT03196362

First Posted

June 20, 2017

Last Updated

June 20, 2017

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03196362

Brief Title

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

Official Title

Impacts of Sequential Treatment Using Fixed Dose Pioglitazone/Metformin Combination Following Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and β-Cell Function in Patients With Newly Diagnosed Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

September 30, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PIO/MET

Arm Type

Active Comparator

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

one tablet of placebo will be given twice daily

Intervention Type

Drug

Intervention Name(s)

Pioglitazone + Metformin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

One tablet of placebo will be given twice daily

Primary Outcome Measure Information:

Title

Remission rate

Description

Remission rate at the end of the study in each group

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

β-cell function

Description

Difference in β-cell secretion capacity at the end of follow up between treatment groups

Time Frame

48 weeks

Title

Insulin sensitivity

Description

Difference in insulin sensitivity at the end of follow up between treatment groups

Time Frame

48 weeks

Title

glycemic control

Description

proportion of patients who achieve A1C<7% at the end of follow-up

Time Frame

48 weeks

Title

Adverse events

Description

difference in AEs at the end of follow-up between treatment groups

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liehua Liu, PHD

Phone

+8613751748843

turkey310@163.com

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanbing Li, MD,PhD

Phone

8602087334331

easd04lyb@126.com

First Name & Middle Initial & Last Name & Degree

Yanbing Li, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

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

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