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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196362
Recruitment Status : Unknown
Verified June 2017 by Yanbing Li, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Yanbing Li, Sun Yat-sen University

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Pioglitazone + Metformin Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PIO/MET
one fixed dose pioglitazone/metformin (15mg/500mg) tablet will be orally administrated twice daily
Drug: Pioglitazone + Metformin
One tablet of fixed dose of Pioglitazone/ Metformin (15mg/30mg) will be given twice daily

Placebo Comparator: placebo
one tablet of placebo will be given twice daily
Drug: Placebo Oral Tablet
One tablet of placebo will be given twice daily




Primary Outcome Measures :
  1. Remission rate [ Time Frame: 48 weeks ]
    Remission rate at the end of the study in each group


Secondary Outcome Measures :
  1. β-cell function [ Time Frame: 48 weeks ]
    Difference in β-cell secretion capacity at the end of follow up between treatment groups

  2. Insulin sensitivity [ Time Frame: 48 weeks ]
    Difference in insulin sensitivity at the end of follow up between treatment groups

  3. glycemic control [ Time Frame: 48 weeks ]
    proportion of patients who achieve A1C<7% at the end of follow-up

  4. Adverse events [ Time Frame: 48 weeks ]
    difference in AEs at the end of follow-up between treatment groups



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly diagnosed type 2 diabetes who have never received any hypoglycemic treatment;
  2. 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%;
  3. Aged between 25 and 65 years,
  4. Body mass index (BMI) 22-35 kg/m2.

Exclusion Criteria:

  1. Type 1 diabetes or special type of diabetes;
  2. Acute diabetic complications of diabetes (DKA, HHS and lactic acidosis etc.)
  3. 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;
  4. 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;
  5. Persistently increased blood pressure >180/110 mmHg;
  6. Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal;
  7. Hemoglobin <100 g/L or need regular blood transfusion;
  8. Use of drugs that may influence blood glucose within 12 weeks;
  9. Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea;
  10. Uncontrolled endocrine gland dysfunction;
  11. Patients with mental or communication disorders;
  12. Chronic cardiac insufficiency, heart function class III and above;
  13. Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study;
  14. Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196362


Contacts
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Contact: Liehua Liu, PHD +8613751748843 turkey310@163.com

Locations
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China, Guangdong
endocrinology department of the first affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yanbing Li, MD,PhD    8602087334331    easd04lyb@126.com   
Principal Investigator: Yanbing Li, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Yanbing Li, Director of Endocrinology and Metabolism Department, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03196362    
Other Study ID Numbers: 20160145
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanbing Li, Sun Yat-sen University:
short-term intensive insulin therapy
pioglitazone
metformin
remission
sequential therapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Metformin
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs