NCT02129985

Brief Summary

Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 2, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

April 10, 2014

Last Update Submit

April 30, 2014

Conditions

Type 2 Diabetes

Keywords

the newly onset type 2 diabetesshort-term insulin treatmentexenatide sequential therapybeta cell functionglycaemic remission

Outcome Measures

Primary Outcomes (2)

  • time to glycaemic remission

    time of glycaemic remission at 1 year after exenatide sequential therapy followed by a short-term insulin intensive treatment

    up to 1 year

  • remission rate of type 2 diabetes at a year.

    remission rate of type 2 diabetes after short-term intensive insulin and exenatide sequencial therapy

    up to 1 year

Secondary Outcomes (1)

  • the beta cell function change

    1 year

Other Outcomes (3)

  • HbA1C level at every 3 months during the whole study

    1 year

  • mean glucose level during the follow without drug intervention

    1 year

  • number of hypoglycemia and severe hypoglycemia during the study

    up to 1 year

Study Arms (2)

Exenatide

EXPERIMENTAL

patients were all received a short-term intensive insulin therapy,then randomised to Exenatide group(10 ug two times a day for three months)

Drug: Exenatide

Metformin

ACTIVE COMPARATOR

patients were all received a short-term intensive insulin therapy,then randomised to metformin group(850mg two times a day for three months)

Drug: Metformin

Interventions

ExenatideDRUG

Exenatide (10 ug/bid for 3 months)

Also known as: GLP-1 receptor agonist
Exenatide
MetforminDRUG

Metformin 850 mg/bid for 3 months

Also known as: Glucophage
Metformin

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed type 2 diabetes without drug treatment
  • years old age
  • Fasting glucose between 7.0-16.7mmol / L
  • BMI at 20 \~ 35 kg/m2 and stable for at least 3 month(weight fluctuations within three months does not exceed 10%)
  • females who have no plan of pregnancy during the study

You may not qualify if:

  • acute or chronic complications of diabetes
  • myocardial infarction or cerebrovascular events within three months
  • serious gastrointestinal diseases
  • other serious concomitant diseases
  • liver or kidney dysfunction:Transaminase (ALT and AST) greater than 3 times the upper limit of the normal range or creatinine levels greater than 133μmol / L
  • GAD antibodies positive
  • history of pancreatitis or pancreatic cancer;
  • pregnant or breastfeeding women.
  • severe hypertension (blood pressure\> 180/110mmhg)
  • using corticosteroids, immunosuppressants and cytotoxic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaolong Zhao

Jingan, Shanghai Municipality, 20041, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ExenatideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsBiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

xiaolong zhao, MD.

CONTACT

86-18918067241xiaolongzhao@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Endocrinology department

Study Record Dates

First Submitted

April 10, 2014

First Posted

May 2, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

May 2, 2014

Record last verified: 2014-04

Locations

CN(1)