Clinical trial NCT00360698: Insulin Glulisine in Type 2 Diabetic Patients
Official title: Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-08-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus, Type 2
* 25 \< BMI \< 45 kg/m²
* 7,5% \< HbA1c \< 9%
* Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months

Exclusion Criteria:

* Type 1 diabetes mellitus
* Treatment with OADs only
* Treatment with thiazolidinediones, with exenatide or with pramlintide
* Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
* Active proliferative diabetic retinopathy,
* Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
* Breast-feeding
* History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
* Treatment with systemic corticosteroids in the 3 months prior to study entry
* Treatment with any investigational product in the 2 months prior to study entry
* Previous treatment with insulin glulisine
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
* Impaired hepatic function
* Impaired renal function
* History of drug or alcohol abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
timeFrame: at the end of treatment (week 24)
Secondary outcomes:
measure: Glycosylated Haemoglobin (HbA1c) Value
timeFrame: at the end of treatment (week 24)
measure: Change in Glycosylated Haemoglobin (HbA1c) Value
timeFrame: from baseline to the end of treatment (week 24)
measure: Daily Mean Plasma Glucose
timeFrame: at the end of treatment (week 24)
measure: Change in Daily Mean Plasma Glucose
timeFrame: from baseline to the end of treatment (week 24)
measure: Change in Weight
timeFrame: from baseline to the end of treatment (week 24)
measure: Daily Dose of Insulin Glargine
timeFrame: at the end of treatment (week 24)
measure: Daily Dose of Insulin Glulisine
timeFrame: at the end of treatment (week 24)
measure: Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
timeFrame: during treatment period (12 weeks)
measure: Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
timeFrame: during treatment period (12 weeks)
measure: Rate of Severe Symptomatic Hypoglycemia
timeFrame: during treatment period (12 weeks)
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-aventis
state: New Jersey
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis
city: Guildford
country: United Kingdom
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: PILORGET Valérie, MD
role: STUDY_DIRECTOR
References: