NCT00366301

Brief Summary

The purpose of this study, which is being conducted at 100 centers throughout the United States, is to determine whether Lantus, a long-acting insulin injection, either alone or in combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with type 2 diabetes. CRP is a marker of chronic low-level inflammation, a new risk factor for diabetes, heart attack, stroke, and other cardiovascular events.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Aug 2006

Typical duration for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 25, 2010

Completed
Last Updated

November 25, 2010

Status Verified

October 1, 2010

Enrollment Period

2.7 years

First QC Date

August 17, 2006

Results QC Date

October 26, 2010

Last Update Submit

October 26, 2010

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesinsulininsulin injectionmetforminC-reactive proteininsulin sensitivityglycemic controlinflammation

Outcome Measures

Primary Outcomes (1)

  • Percentage Reduction in C-reactive Protein (CRP)

    14 weeks

Study Arms (4)

Placebo pill

PLACEBO COMPARATOR

Placebo pill

Drug: Placebo pill

Metformin Pill

ACTIVE COMPARATOR

Metformin pill

Drug: metformin

Insulin Glargine plus placebo pill

ACTIVE COMPARATOR

Insulin glargine plus placebo pill

Drug: Insulin glargine injectionDrug: Placebo pill

Insulin Glargine plus metformin pill

ACTIVE COMPARATOR

Insulin Glargine plus metformin pill

Drug: Insulin glargine injectionDrug: metformin

Interventions

Insulin glargine injectionDRUG

Once daily for 14 weeks

Also known as: Lantus
Insulin Glargine plus metformin pillInsulin Glargine plus placebo pill
metforminDRUG

Up to 4 pils per day (2g per day) maximum

Insulin Glargine plus metformin pillMetformin Pill
Placebo pillDRUG

Up to 4 pills per day

Insulin Glargine plus placebo pillPlacebo pill

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 18 to 79
  • Type 2 diabetes, treated only by diet or oral drugs other than metformin
  • HbA1c greater than or equal to 7% and less than or equal to 10%
  • C-reactive protein greater than or equal to 2 mg/L

You may not qualify if:

  • Baseline use of metformin or insulin
  • Type 1 diabetes, history of ketoacidosis or positive anti-GAD antibody
  • History of congestive heart failure requiring drug therapy
  • Active liver disease
  • Kidney impairment
  • Recent initiation or change in dose of statins, fibric acid derivatives, angiotensin receptor blockers, nonsteroidal anti-inflammatory agents, or corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • Srivastava PK, Pradhan AD, Cook NR, Ridker PM, Everett BM. Randomized Trial of the Effects of Insulin and Metformin on Myocardial Injury and Stress in Diabetes Mellitus: A Post Hoc Exploratory Analysis. J Am Heart Assoc. 2017 Dec 23;6(12):e007268. doi: 10.1161/JAHA.117.007268.

    PMID: 29275373DERIVED

  • Pradhan AD, Everett BM, Cook NR, Rifai N, Ridker PM. Effects of initiating insulin and metformin on glycemic control and inflammatory biomarkers among patients with type 2 diabetes: the LANCET randomized trial. JAMA. 2009 Sep 16;302(11):1186-94. doi: 10.1001/jama.2009.1347.

    PMID: 19755697DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceInflammation

Interventions

Insulin GlargineMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Aruna Pradhan
Organization
Brigham and Women's Hospital
apradhan@partners.org
617-732-8777

Study Officials

  • Paul M Ridker, MD, MPH

    Brigham and Women's Hospital

    STUDY CHAIR

  • Aruna Das Pradhan, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

August 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

November 25, 2010

Results First Posted

November 25, 2010

Record last verified: 2010-10

Locations

US(1)