N/A
N=882
Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01060059 ↗Enrolled (actual)
882
Serious AEs
2.4%
Results posted
Jan 2014
Primary outcome: Primary: Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12. — 35.0; 15.8 percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- exenatide (Drug); basal insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12. |
35.0; 15.8 | — |
| SECONDARY Changes in HbA1c From Baseline to Month 12 |
-1.1; -1.4 | — |
| SECONDARY Changes in Fasting Blood Glucose From Baseline to Month 12 |
-26.7; -51.4 | — |
| SECONDARY Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12 |
49.4; 51.1 | — |
| SECONDARY Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12 |
39.0; 22.2 | — |
| SECONDARY Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12 |
13.1; 4.9 | — |
| SECONDARY Changes in Weight From Baseline to Month 12 |
-3.9; 0.2 | — |
| SECONDARY Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12 |
43.0; 17.6 | — |
| SECONDARY Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12 |
29.7; 10.7 | — |
| SECONDARY Changes in Fasting Total Cholesterol Between Baseline and Month 12 |
-6.0; -7.5 | — |
| SECONDARY Changes in Fasting HDL Between Baseline and Month 12 |
1.3; 0.2 | — |
| SECONDARY Changes in Fasting LDL Between Baseline and Month 12 |
-4.6; -4.5 | — |
| SECONDARY Changes in Fasting Triglycerides Between Baseline and Month 12 |
-16.5; -30.2 | — |
| SECONDARY Changes in Diastolic Blood Pressure Between Baseline and Month 12 |
-2.4; 0.2 | — |
| SECONDARY Changes in Systolic Blood Pressure Between Baseline and Month 12 |
-4.6; -1.0 | — |
| SECONDARY Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12 |
3.6; 8.2 | — |
| SECONDARY Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline |
246; 247; 198; 191; 371; 363 | 0.831 |
| SECONDARY Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline |
8.7; 9.2 | <0.001 sig |
| SECONDARY Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline |
9.0; 12.4 | 0.055 |
| SECONDARY Factor of Older Age Associated With Treatment Choice at Baseline |
59.2; 65.9 | <0.001 sig |
| SECONDARY Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline |
35.4; 29.4 | <0.001 sig |
| SECONDARY Factor of Greater Height Associated With Treatment Choice at Baseline |
165.8; 164.4 | 0.026 sig |
| SECONDARY Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline |
0.9; 1.0; 44.7; 46.9; 181.1; 182.7 | 0.007 sig |
Summary
Although the efficacy and safety profile of exenatide has been well established, few data exist on the real world results of exenatide treatment in specific populations and clinical settings. This study is intended to fill this gap through observing and collecting prospective data from a population of Italian patients initiating treatment with either exenatide or basal insulin formulations after failure to achieve glycemic control with oral antihyperglycemic agents (OHA).
Observational studies represent noninterventional research; therefore, this study does not involve randomization of patients to particular comparator arms or therapies. The term "noninterventional" means that the healthcare providers decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice. Patients enrolled in this study are enrolling for the collection of their data on observations made during normal clinical practice.
Eligibility Criteria
Inclusion Criteria
- Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c > 7.0%
- Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA
- Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study
- Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease
- Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
- Have been fully informed and given their written consent for use of their data
Data sourced from ClinicalTrials.gov (NCT01060059). 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.