N/A
Completed N=60
Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
Source: ClinicalTrials.gov NCT01089569 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: HbA1c Change — 6.4; 6.4; 6.2; 7.8 %HbA1c
Summary
The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change |
6.4; 6.4; 6.2; 7.8; 7.6; 7.6 | — |
| SECONDARY Change From Baseline in Incidence of Hypoglycemia (Frequency) |
.7; .8; .6 | — |
| SECONDARY Change From Baseline in Incidence of Hypoglycemia (Degree) |
1.7; 1.7; 1.3 | — |
| SECONDARY Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve) |
-2; -2.9; -2 | — |
| SECONDARY Change From Baseline in CGM Glucose Variability |
-9; -7.7; -12.1 | — |
| SECONDARY Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC) |
-1207.1; -1476.2; -1315 | — |
| SECONDARY Change From Baseline in Weight Changes |
-13.5; -0.5; -10.3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects ≥18 and ≤75 years of age
- Clinical diagnosis of type 2 diabetes
- Diabetes duration ≥ 1 year
- HbA1c ≥7.0%
- Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)
Exclusion Criteria
- Previously treated with insulin or incretin-based therapy
- Treated with a thiazolidinedione within past 6 weeks
- Taken oral or injected prednisone or cortisone medications in the previous 30 days
- Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
- Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)
- eGFR (Estimated Glomerular Filtration Rate) 2x Upper Limit of Normal (ULN)
- Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
- Currently pregnant or planning pregnancy during the study period
- Unable to follow the study protocol
- Unable to speak, read and write in English
- Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
- At the investigator's discretion for other medical or psychological reasons
Data sourced from ClinicalTrials.gov (NCT01089569). 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.