Phase 4
Completed N=588
Insulin Glargine "All to Target" Trial
Source: ClinicalTrials.gov NCT00384085 ↗Enrolled (actual)
588
Serious AEs
11.3%
Results posted
Apr 2011
Primary outcomePrimary: Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites) — 43.3; 38.6; 35.3; 32.3 percentage of participants — p=0.0628
Summary
The primary objectives were:
* To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%) at Week 60
* To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites) |
43.3; 38.6; 35.3; 32.3; 21.4; 29.1 | 0.0628 |
| PRIMARY Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population |
9.30; 9.06; -2.30; -1.97 | 0.0359 sig |
| PRIMARY Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis) |
44.1; 38.1; 34.4; 32.0; 21.5; 29.9 | 0.0313 sig |
| SECONDARY Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30) |
-2.45; -2.13 | 0.0565 |
| SECONDARY Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30) |
51.1; 39.5 | 0.0140 sig |
| SECONDARY Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl |
23.0; 25.0; 14.1; 55.7; 52.2; 58.4 | 0.9268 |
| SECONDARY Adjusted Incidence Rate of Hypoglycemia |
74.40; 74.78; 83.15; 60.14; 62.50; 71.98 | — |
| SECONDARY Adjusted Hypoglycemic Event Rates (Event/Patient-year) |
14.50; 12.85; 20.42; 7.23; 7.11; 12.23 | — |
Eligibility Criteria
- Male or female patients
- 30 to 80 years of age
- Body Mass Index 7.5% and >7.0% at randomization
- On stable dual or triple oral therapy for at least 3 months
- Oral agents in 2 or 3 of the following classes: SU or repaglinide, biguanide, or TZD, willing and able to perform self-monitoring of BG
- Females of child-bearing potentially were required to be willing and able to use adequate contraception
Data sourced from ClinicalTrials.gov (NCT00384085). 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. Informational only — not medical advice.