NCT00036504

Brief Summary

The purposes of this study are to determine: 1. If patients taking insulin lispro LM with metformin will have better overall control of their blood sugar than patients taking a long acting insulin comparator with metformin. 2. If there is a difference in the way the two treatments affect blood sugar control before and after meals and at night. 3. If there is a difference in the insulin dose required with the two treatments. 4. If there is a difference in the numbers of times patients experience low blood sugar with the two treatments. 5. If there is a difference in the effect on patients's body weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

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

Timeline
Completed

Started Aug 2001

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

13 active sites

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

August 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

First QC Date

May 10, 2002

Last Update Submit

October 12, 2010

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus, insulin deficiency, hyperglycemia

Interventions

Insulin Lispro low mixtureDRUG

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes.
  • At least 30 years old and less than 80 years old.
  • Using oral agents without insulin for 30 days prior ot study.
  • Willing to start insulin injections using a pen device.
  • Keep a patient diary.

You may not qualify if:

  • Undergoing therapy for cancers.
  • History of renal transplant or receiving renal dialysis.
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
  • Women who are breastfeeding.
  • Have been treated with a drug within the last 30 days that has not received regulatory approval.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Walnut Creek, California, United States

Location

Unknown Facility

New Britain, Connecticut, United States

Location

Unknown Facility

Longwood, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Fayetteville, Georgia, United States

Location

Unknown Facility

Boise, Idaho, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Unknown Facility

Mount Laurel, New Jersey, United States

Location

Unknown Facility

New Brunswick, New Jersey, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Related Publications (5)

  • Malone JK, Kerr LF, Campaigne BN, Sachson RA, Holcombe JH; Lispro Mixture-Glargine Study Group. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther. 2004 Dec;26(12):2034-44. doi: 10.1016/j.clinthera.2004.12.015.

    PMID: 15823767RESULT

  • Hirsch IB, Yuan H, Campaigne BN, Tan MH. Impact of prandial plus basal vs basal insulin on glycemic variability in type 2 diabetic patients. Endocr Pract. 2009 May-Jun;15(4):343-8. doi: 10.4158/EP08308.ORR.

    PMID: 19454394RESULT

  • Chan JY, Leyk M, Frier BM, Tan MH. Relationship between HbA1c and hypoglycaemia in patients with type 2 diabetes treated with different insulin regimens in combination with metformin. Diabetes Metab Res Rev. 2009 Mar;25(3):224-31. doi: 10.1002/dmrr.929.

    PMID: 19156705RESULT

  • Shrom D, Sarwat S, Ilag L, Bloomgarden ZT. Does A1c consistently reflect mean plasma glucose? J Diabetes. 2010 Jun;2(2):92-6. doi: 10.1111/j.1753-0407.2010.00066.x. Epub 2010 Jan 22.

    PMID: 20923490RESULT

  • Sarwat S, Ilag LL, Carey MA, Shrom DS, Heine RJ. The relationship between self-monitored blood glucose values and glycated haemoglobin in insulin-treated patients with Type 2 diabetes. Diabet Med. 2010 May;27(5):589-92. doi: 10.1111/j.1464-5491.2010.02955.x.

    PMID: 20536957RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2002

First Posted

May 13, 2002

Study Start

August 1, 2001

Study Completion

August 1, 2002

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations

US(13)