NCT02535299

Brief Summary

Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and Par-4.

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
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

August 21, 2015

Last Update Submit

September 10, 2016

Conditions

GLP-1；Metformin；Telomere-telomerase System；Par-4

Keywords

telomere-telomerasePar-4GLP-1metformin

Outcome Measures

Primary Outcomes (1)

  • physiological parameter:glycosylated hemoglobin A1c

    up to 6 months;;HbA1c was measured by a certified hospital laboratory according to established and approved protocols

    up to 6 months;

Secondary Outcomes (4)

  • physiological parameter:the concentration of Par-4

    up to 6 months;

  • physiological parameter:telomere length

    up to 6 months;

  • physiological parameter:telomease activity

    up to 6 months;

  • physiological parameter:TNF-α

    up to 6 months;

Study Arms (1)

insulin

EXPERIMENTAL

basic insulin treatment：glargine 10-30 units once a day based on the glucose control for 6 months.

Drug: LiraglutideDrug: Metformin

Interventions

LiraglutideDRUG

GLP-1 analog (1.2mg-1.8mg/day) treatment for 6 months

Also known as: Victoza
insulin
MetforminDRUG

Metformin(1500mg-2000mg/day) treatment for 6 months

Also known as: Glucophage
insulin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly dignosised type 2 diabetes according to WHO criteria.glycated hemoglobin (HbA1c) was more than 10%;
  • Seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD);

You may not qualify if:

  • Type 1 diabetes mellitus,presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and GAD；
  • Gestational diabetes;
  • patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

LiraglutideMetformin

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the Third Military Medical University

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 28, 2015

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

CN(1)