Treatment Strategies in Patients with Type 2 Diabetes Mellitus Not Achieving Glycemic Control while on Therapy with Premixed Insulin Analogues and Metformin: A Comparison of Insulin Lispro MM Intensive Mixture Therapy with Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70 - S019

Eli Lilly and Company Ltd.0 sites270 target enrollmentJuly 27, 2006

Overview

No summary available.

Registry

who.int

Start Date

July 27, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Eli Lilly and Company Ltd.

•1\. Have type 2 diabetes (World Health Organization \[WHO] classification).
•2\. Are at least 30 years of age and less than 75 years of age.
•3\. 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.
•4\. 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
•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].
•5\. As determined by the investigator, are capable and willing to
•continue injections of insulin while continuing to use metformin as specified in inclusion Criterion \[3],
•learn how to use the insulin injection pen(s),
•perform self blood glucose monitoring,
•adjust doses of insulin according to the algorithm provided,

•7\. Are taking any other OAMs not mentioned in inclusion criterion \[3].
•8\. Have a body mass index greater than 40 kg/m2\.
•9\. Have had more than one episode of severe hypoglycemia, as defined in Section 6\.4, within 6 months prior to entry into the study.
•10\. Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
•11\. Are women who are breastfeeding.
•12\. have cardiac disease with functional status that is Class III or IV (American Hearth Association)
•13\. Have congestive heart failure.
•14\. Have a history of renal transplantation or are currently receiving renal dialysis.
•15\. Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (ALT or AST greater than 2 times the upper limit of the reference range as defined by the local laboratory).
•16\. Are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.