Phase 4
N=135
Insulin Glulisine in Type 2 Diabetic Patients
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00360698 ↗Enrolled (actual)
135
Serious AEs
2.8%
Results posted
Dec 2009
Primary outcome: Primary: Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% — 22.4; 8.8 percentage of participants — p=0.0499
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin Glargine (Drug); Glimepiride (Drug); Insulin Glulisine (Drug); Metformin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% |
22.4; 8.8 | 0.0499 sig |
| SECONDARY Glycosylated Haemoglobin (HbA1c) Value |
7.5; 7.8 | — |
| SECONDARY Change in Glycosylated Haemoglobin (HbA1c) Value |
-0.37; -0.11 | 0.029 sig |
| SECONDARY Daily Mean Plasma Glucose |
154.7; 165.8 | — |
| SECONDARY Change in Daily Mean Plasma Glucose |
-15.01; -2.07 | 0.0109 sig |
| SECONDARY Change in Weight |
0.46; 0.22 | 0.5762 |
| SECONDARY Daily Dose of Insulin Glargine |
54.7; 62.2 | — |
| SECONDARY Daily Dose of Insulin Glulisine |
12.8 | — |
| SECONDARY Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL |
8.19; 7.68 | 0.958 |
| SECONDARY Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL |
1.62; 3.95 | 0.302 |
| SECONDARY Rate of Severe Symptomatic Hypoglycemia |
0.00; 0.20 | 0.192 |
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.
Data sourced from ClinicalTrials.gov (NCT00360698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.