NCT00574912

Brief Summary

The study is to determine the dose response relationship of insulin glargine in type 2 diabetes over a 24-hour period and measuring the differences in glucose production among the differing doses of glargine. Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will show differing effects on endogenous glucose production, glucose disposal and carbohydrate and lipid flux.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

August 3, 2015

Completed
Last Updated

April 17, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

December 13, 2007

Results QC Date

December 18, 2014

Last Update Submit

March 17, 2017

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesInsulin GlargineEndogenous Glucose Production

Outcome Measures

Primary Outcomes (1)

  • Maximum Glucose Infusion Rate

    measuring the changes in glucose infusion rate during the 24 hour experimental period.

    24 hours

Study Arms (1)

Placebo then Insulin Glargine

EXPERIMENTAL

Placebo: administer single dose of Placebo subcutaneously (SC) with blood glucose monitoring over 24 hours. Then Insulin Glargine SQ 8 weeks later, in increasing doses (0.5, 1.0, 1.5, 2.0 u/kg body wt.) with blood glucose monitoring monitoring over a 24 hour period. Each dose is separated by 8 weeks (5 separate study visits)

Drug: PlaceboDrug: Insulin Glargine 0.5 u/kg body wt SCDrug: Insulin Glargine 1.0 u/kg body wt SCDrug: Insulin Glargine 1.5 u/kg body wt SCDrug: Insulin Glargine 2.0 u/kg body wt SC

Interventions

PlaceboDRUG

single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours

Also known as: Lantus
Placebo then Insulin Glargine
Insulin Glargine 0.5 u/kg body wt SCDRUG

8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits)

Also known as: Lantus
Placebo then Insulin Glargine
Insulin Glargine 1.0 u/kg body wt SCDRUG
Also known as: Lantus
Placebo then Insulin Glargine
Insulin Glargine 1.5 u/kg body wt SCDRUG
Also known as: Lantus
Placebo then Insulin Glargine
Insulin Glargine 2.0 u/kg body wt SCDRUG
Also known as: Lantus
Placebo then Insulin Glargine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults (males or females) with type 2 diabetes for at least six (6) months. May be using oral agents (SUs, metformin, acarbose or glitinides) with or without insulin.
  • HgbA1c 7 -12%
  • Age 18-70 years
  • BMI 27-40 kg/m²

You may not qualify if:

  • Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study
  • Evidence of hepatic, renal or cardiac failure
  • Abnormal results following screening tests
  • Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception
  • Currently using TZDs
  • History of alcoholism or drug abuse within 12 months of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Wang Z, Hedrington MS, Gogitidze Joy N, Briscoe VJ, Richardson MA, Younk L, Nicholson W, Tate DB, Davis SN. Dose-response effects of insulin glargine in type 2 diabetes. Diabetes Care. 2010 Jul;33(7):1555-60. doi: 10.2337/dc09-2011. Epub 2010 Mar 31.

    PMID: 20357371DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Stephen N. Davis
Organization
University of Maryland, Baltimore
sdavis@medicine.umaryland.edu
4103282488

Study Officials

  • Stephen N. Davis, MD, FRCP

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Medicine, University of Maryland, Baltimore

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 17, 2007

Study Start

March 1, 2007

Primary Completion

September 1, 2009

Study Completion

January 1, 2010

Last Updated

April 17, 2017

Results First Posted

August 3, 2015

Record last verified: 2017-03

Locations

US(1)