N/A
Completed N=2,388
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
Source: ClinicalTrials.gov NCT00635492 ↗Enrolled (actual)
2,388
Serious AEs
—
Results posted
Jul 2014
Primary outcomePrimary: Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. — 53.9; 60.6; 67.8; 70.6 probability (%)
Summary
Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. |
53.9; 60.6; 67.8; 70.6 | — |
| SECONDARY Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline |
35.3; 29.7 | <0.0001 sig |
| SECONDARY Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline |
8.4; 9.2 | <0.0001 sig |
| SECONDARY Older Age Associated With Treatment Choice at Baseline |
58.1; 63.7 | <0.0001 sig |
| SECONDARY Disinhibited Eating Associated With Treatment Choice at Baseline |
43.52; 34.38 | 0.0083 sig |
| SECONDARY Higher Random Glucose Associated With Treatment Choice at Baseline |
10.37; 12.13 | 0.0141 sig |
| SECONDARY Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline |
9.28; 9.91 | 0.0107 sig |
| SECONDARY Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline |
12; 1; 131; 237; 910; 905 | 0.0193 sig |
| SECONDARY Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline |
2.82; 3.00 | 0.0138 sig |
| SECONDARY Changes in HbA1c From Baseline to Month 24 |
-1.03; -1.71 | — |
| SECONDARY Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24 |
26.9; 28.5 | — |
| SECONDARY Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24 |
12.5; 10.7 | — |
| SECONDARY Changes in Weight From Baseline to Month 24 |
-3.22; 2.16 | — |
| SECONDARY Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months |
29.4; 5.0 | — |
| SECONDARY Incidence of Hypoglycemia Between Baseline and 24 Months |
17.5; 35.2 | — |
| SECONDARY Reasons for Discontinuation of Baseline Regimen |
170; 87; 91; 11; 69; 15 | — |
| SECONDARY Factors Associated With Treatment Change in Insulin Cohort |
1.118; 0.960; 2.532; 0.437; 0.676; 0.549 | <0.0001 sig |
| SECONDARY Factors Associated With Treatment Change in Exenatide BID Cohort |
1.463; 0.601 | 0.028 sig |
| SECONDARY Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months |
94.4; 94.1; 90.4; 92.3 | — |
| SECONDARY Number of Contacts With Health Care Providers Between Baseline and 24 Months |
7.17; 7.64; 19.00; 24.58 | — |
| SECONDARY Percentage of Patients Hospitalized Between Baseline and 24 Months |
4.7; 6.4; 4.3; 7.8 | — |
Eligibility Criteria
Inclusion Criteria
- are aged 18 or above
- diagnosed with type 2 diabetes
- have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
- have not previously been treated with either insulin or exenatide
- 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
- have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.
Data sourced from ClinicalTrials.gov (NCT00635492). 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.