Lispro MM Intensive Mixture Therapy With Progressive Dose-Titration of Lispro LM or Biphasic Insulin Aspart 30/70 (S019) - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00393705

Purpose

Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations BID 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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin Biphasic Aspart 30/70 Drug: Insulin lispro Low Mix Drug: Insulin lispro Mid Mix	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin lispro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison of Insulin Lispro MM Intensive Mixture Therapy With Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To compare efficacy of two insulin treatment strategies in patients with type 2 Diabetes [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percentage of patients achieving HbA1c <7% and HbA1c </=6.5% in both treatment groups [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
2-hour postprandial plasma glucose concentrations after the midday meal from self-monitored 7-point plasma glucose [ Time Frame: 4-8-12-16 weeks ] [ Designated as safety issue: Yes ]
Mean 2-hour postprandial blood glucose excursions after midday meal [ Time Frame: 4-8-12-16 weeks ] [ Designated as safety issue: Yes ]
Mean daily blood glucose [ Time Frame: 2-4-6-8-10-12-16 weeks ] [ Designated as safety issue: Yes ]
Incidence and rate of self-reported hypoglycemic episodes [ Time Frame: 2-4-6-8-10-12-16 weeks ] [ Designated as safety issue: Yes ]
Change in weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Compare the total daily insulin dose in the treatment groups [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Insulin lispro LM + insulin lispro MM	Drug: Insulin lispro Low Mix Patient adjusted dose, TID, injected SC x 16 weeks Drug: Insulin lispro Mid Mix Patient adjusted dose, TID, injected SC x 16 weeks
2: Active Comparator Insulin Biphasic Aspart 30/70	Drug: Insulin Biphasic Aspart 30/70 Patient adjusted dose, Bid, injected SC x 16 weeks

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 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 mg/dl [10.0 mmol/l]. accordance with local regulations.

Exclusion Criteria:

Are taking any other OAMs not mentioned in inclusion criterion [3].
Have a body mass index greater than 40 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393705

Locations

Croatia
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, Croatia, HR-10000
Poland
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, Poland, 15-276
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.
Rzeszow, Poland, 35-0723
Romania
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, Romania, 020475
South Africa
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, South Africa, 1619
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, South Africa, 7708
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, South Africa, 7580
Turkey
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, Turkey, 42075
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, Turkey, 34662

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10916, F3Z-MC-S019
Study First Received:	October 26, 2006
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00393705 History of Changes
Health Authority:	Poland: Ministry of Science and Higher Education

Keywords provided by Eli Lilly and Company:

diabetes
type 2

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus

Insulin LISPRO
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009