Phase 3
Completed N=191
Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes
Source: ClinicalTrials.gov NCT00348374 ↗Enrolled (actual)
191
Serious AEs
3.3%
Results posted
Mar 2010
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment — -1.4; -1.6 percent
Summary
The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated hemoglobin (A1C) levels.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment |
-1.4; -1.6 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit |
-0.8; -0.8; -1.1; -1.2; -1.3; -1.5 | — |
| SECONDARY Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24 |
8; 9; 24; 27; 33; 41 | — |
| SECONDARY Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24 |
8; 8; 24; 26; 33; 40 | — |
| SECONDARY Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles |
11.1; 9.3; -36.3; -19.3; -32.2; -27.9 | — |
| SECONDARY Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12 |
-49.8; -30.5; -27.9; -44.4; -58.8; -50.3 | — |
| SECONDARY Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24 |
-25.1; -34.8; -59.5; -86.0; -64.9; -59.8 | — |
| SECONDARY Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests |
-4.4; 1.2; -6.8; -6.7; -0.2; 0.5 | — |
| SECONDARY Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests |
— | — |
| SECONDARY Change From Baseline Weight at Each Visit |
-0.5; -0.3; 0.5; 0.9; 0.1; 0.9 | — |
| SECONDARY Change From Baseline in Fasting Plasma Lipids |
-4.4; 1.2; -0.2; 0.5; 1.2; 1.4 | — |
| SECONDARY Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone) |
8.8; 4.3; 14.1; 9.1; 12.8; 14.0 | — |
| SECONDARY Baseline Prandial Insulin Dose (at Each Meal) at Each Visit |
4.14; 4.10; 4.06; 4.25; 4.33; 4.35 | — |
| SECONDARY Number of Subjects With Hypoglycemic Events |
38; 35; 38; 35; 0; 0 | — |
| SECONDARY Number of Total Hypoglycemic Events |
106; 121; 106; 121; 0; 0 | — |
| SECONDARY Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment |
85.3; 92.9; 85.3; 92.9; 85.3; 92.9 | — |
| SECONDARY Crude Hypoglycemic Event Rate |
1.2; 1.3; 1.2; 1.3; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) |
— | — |
| SECONDARY Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24 |
— | — |
| SECONDARY Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS) |
-30.4; -33.0; -19.4; -23.4 | — |
| SECONDARY Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS) |
-3.4; 2.3; -3.6; -0.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin, not at glycemic goal.
Exclusion Criteria
- lung disease
- current smoking or discontinued smoking within past 6 months
Data sourced from ClinicalTrials.gov (NCT00348374). 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.