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Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194945
Recruitment Status : Not yet recruiting
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Collaborators:
Nanfang Hospital of Southern Medical University
Guangdong Provincial People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Zhujiang Hospital
Guangzhou First People's Hospital
The Third Affiliated Hospital of Guangzhou Medical University
The Third Affiliated Hospital of Southern Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yanbing Li, Sun Yat-sen University

Brief Summary:

Short-term intensive insulin therapy(SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. However, proportion of patients with response gradually decreases over time. There is no consensus on which treatment should be given in order to maintain the benefit in glycemic control and β cell recovery. In this multi-center, randomized, controlled study, effects of various sequential treatments ( metformin, linagliptin and combined with both drugs) on long-term blood glucose control as well as preservation of β cell function after SIIT were investigated.

In total, 448 patients with newly diagnosed type 2 diabetes who meet the inclusive criteria will be enrolled in eight centers in China. After baseline assessments, all patients will be treated with insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Different treatments will be applied to patients for 48 weeks according to randomization: Group A: Linagliptin 5 mg Qd + Metformin 0.5 g bid; Group B: Linagliptin 5 mg Qd; Group C: Metformin 0.5 g bid; Group D: No oral drugs. Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of the study. Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of study; differences in β-cell function , insulin sensitivity, GLP-1 and glucagon secretion among treatment groups, and differences in adverse events among treatment groups.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: CSII followed by Lina+MET Drug: CSII followed by Lina Drug: CSII followed by MET Drug: CSII alone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Linagliptin and Metformin Monotherapy or Combined Sequential Treatment After Early Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and Function of β Cells in Patients With Type 2 Diabetes
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Linagliptin plus metformin
CSII followed by Linagliptin 5 mg Qd + Metformin 0.5 g bid for 48 weeks
Drug: CSII followed by Lina+MET
short-term intensive CSII followed by Linagliptin 5mg qd and Metformin 0.5g bid for 48 weeks
Other Name: CSII+Lina+Met

Active Comparator: Linagliptin
CSII followed by Linagliptin 5mg Qd for 48 weeks
Drug: CSII followed by Lina
short-term intensive CSII followed by Linagliptin 5mg qd for 48 weeks
Other Name: CSII+Lina

Active Comparator: Metformin
CSII followed by Metformin 0.5 bid for 48 weeks
Drug: CSII followed by MET
short-term intensive CSII followed by Metformin 0.5g bid for 48 weeks
Other Name: CSII+Met

Active Comparator: Lifestyle alone
No OHA is given after CSII
Drug: CSII alone
No OHA is given after short-term intensive CSII
Other Name: CSII




Primary Outcome Measures :
  1. proportion of subjects with optimal glycemic control [ Time Frame: 48 weeks ]
    proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of sequential treatment in each treatment group.


Secondary Outcome Measures :
  1. proportion of subjects with excellent glycemic control [ Time Frame: 48 weeks ]
    proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of sequential treatment in each treatment group.

  2. Change of β cell function [ Time Frame: 48 weeks ]
    Differences in β-cell indicators among treatment arms at the end of study.

  3. Change of insulin sensitivity [ Time Frame: 48 weeks ]
    Differences in insulin sensitivity indicators among treatment arms at the end of study.

  4. Incidence of adverse events [ Time Frame: 48 weeks ]
    Differences in incidence of adverse events among treatment arms at the end of study.



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 type 2 diabetes who have never received any hypoglycemic treatment, or patients with type 2 diabetes <1 year from diagnosis who have used no more than 1 type of hypoglycemic drug for no more than 1 week and discontinued for more than 4 weeks before enrollment;
  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, body mass index (BMI) 22-35 kg/m2.

Exclusion Criteria:

  1. Type 1 diabetes or special type of diabetes;
  2. Acute complications of diabetes (including DKA, HHS and lactic acidosis)
  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): NCT03194945


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
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Nanfang Hospital of Southern Medical University
Guangdong Provincial People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Zhujiang Hospital
Guangzhou First People's Hospital
The Third Affiliated Hospital of Guangzhou Medical University
The Third Affiliated Hospital of Southern Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine

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Responsible Party: Yanbing Li, Director of Endocrinology and Metabolism Department, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03194945    
Other Study ID Numbers: 2016146
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yanbing Li, Sun Yat-sen University:
Type 2 diabetes mellitus
Continuous subcutaneous insulin infusion
Metformin
Linagliptin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Metformin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action