Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00135096
• Date of registration: 23/08/2005
• Primary sponsor: Sanofi-Aventis
• Public title: Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin
• Scientific title: APIDRA® (Insulin Glulisine) Administered Premeal vs Postmeal in Adult Subjects With Type 2 Diabetes Mellitus Receiving LANTUS® (Insulin Glargine) as Basal Insulin: a Multicenter, Randomized, Parallel, Open Label Clinical Study
• Date of first enrolment: August 2004
• Target sample size: 345
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00135096
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Karen Barch, B.S.
• Affiliation: Sanofi-Aventis

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus for at least six months

- 18 to 70 years of age, inclusive

- A1c = 7.5% and = 10%

- At least 3 months of continuous insulin and/or insulin analogue therapy (on at least
2 injections per day) +/- metformin prior to study entry

- Negative glutamic acid decarboxylase (GAD) autoantibodies

- Ability and willingness to perform self-monitoring of blood glucose (SMBG) at least
four times a day, and at least 7 times daily during the 7-point blood glucose (BG)
profile measurement days

- Ability and willingness to adhere to, and be compliant with, the study protocol

- Must be able to read English or Spanish at the sixth grade level in order to complete
the patient-reported outcomes component of the study

- Signed informed consent

Exclusion Criteria:

- Subjects treated with sulfonylureas, thiazolidinediones (TZDs), or any other oral
antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with
or without metformin

- Planned pregnancy; or pregnant or lactating females

- For subjects treated with metformin: serum creatinine = 1.5 mg/dL (133 µmol/L) for
males or = 1.4 mg/dL (124 µmol/L) for females

- Serum creatinine = 3.0 mg/dL (266 µmol/L)

- Any clinically significant renal disease (other than proteinuria) or hepatic disease

- Serum ALT or AST levels greater than 2.5 X the upper limit of normal

- Any current malignancy or any cancer within the past 5 years (except for adequately
treated basal cell skin cancer or cervical carcinoma in situ)

- Diagnosis of dementia or mental condition rendering the subject unable to understand
the nature, scope, and possible consequences of the study

- Diagnosis of impaired dexterity or vision rendering the subject unable to administer
multiple daily injections (MDIs)

- Cardiac status New York Heart Association (NYHA) III-IV

- Hypersensitivity to Lantus or Apidra or any of their components

- Any disease or condition (including abuse of illicit drugs, prescription medicines or
alcohol) that, in the opinion of the investigator or sponsor, may interfere with the
completion of the study.

- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to
return for follow-up visits, and unlikelihood of completing the study

- Subject is the investigator or any sub-investigator, research assistant, pharmacist,
study coordinator, other staff or relative thereof directly involved in the conduct
of the protocol



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: insulin glargine

Drug: insulin glulisine

Primary Outcome(s)

Compare change in weight from baseline to study week 52 in the per-protocol population of premeal Apidra vs postmeal Apidra, in patients receiving Lantus as basal insulin [Time Frame: 52 weeks]

Secondary ID(s)

HMR1964A_3503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors