NCT00393705

Brief Summary

Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
302

participants targeted

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

Timeline
Completed

Started Oct 2006

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
5 countries

9 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

October 1, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 27, 2010

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

2.4 years

First QC Date

October 26, 2006

Results QC Date

March 31, 2010

Last Update Submit

July 15, 2010

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetestype 2

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c (HbA1c) at 16 Week Endpoint

    16 weeks

Secondary Outcomes (9)

  • Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint

    16 weeks

  • Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint

    Baseline, 16 Weeks

  • 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint

    16 weeks

  • Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint

    16 weeks

  • Mean Daily Blood Glucose Values at 16 Week Endpoint

    16 weeks

  • +4 more secondary outcomes

Study Arms (2)

insulin lispro LM + insulin lispro MM

EXPERIMENTAL

Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.

Drug: insulin lispro LMDrug: insulin lispro MM

Insulin Biphasic Aspart 30/70 or Insulin Lispro LM

ACTIVE COMPARATOR

Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).

Drug: Insulin Biphasic Aspart 30/70Drug: insulin lispro LM

Interventions

Insulin Biphasic Aspart 30/70DRUG

Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks

Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
insulin lispro LMDRUG

Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.

Also known as: Low Mix, Humalog
insulin lispro LM + insulin lispro MM
insulin lispro MMDRUG

Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks

Also known as: Mid Mix, Humalog
insulin lispro LM + insulin lispro MM

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have type 2 diabetes (World Health Organization \[WHO\] classification).
  • Are at least 30 years of age and less than 75 years of age.
  • Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 milligrams (mg) of metformin per day for at least 60 days immediately prior to the study.
  • Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or
  • Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter \[mmol/l\]).
  • Have given written informed consent to participate in this study in accordance with local regulations.

You may not qualify if:

  • Have a body mass index greater than 40 kilograms per meter squared (kg/m2).
  • Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
  • Have congestive heart failure.
  • Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Zagreb, HR-10000, Croatia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bialystok, 15-276, Poland

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rzeszów, 35-0723, Poland

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bucharest, 020475, Romania

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kempton Park, 1619, South Africa

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kenilworth, 7708, South Africa

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kuilsriver, 7580, South Africa

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Istanbul, 34662, Turkey (Türkiye)

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Konya, 42075, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 30, 2006

Study Start

October 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 20, 2010

Results First Posted

April 27, 2010

Record last verified: 2010-07

Locations

PL(2)RO(1)CR(1)ZA(3)TU(2)