Primary outcomeMean· baseline to final visit (32 weeks)
HbA1c Change
| Group | Value (%HbA1c) | Spread |
|---|---|---|
| Exenatide | 6.4 | 0.3 |
| Insulin Glargine | 6.4 | 0.5 |
| Exenatide + Insulin Glargine | 6.2 | 0.5 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataContinuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
NCTNCT01089569 (opens ClinicalTrials.gov in a new tab)Other id03951-10-C
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 60 participants (actual)
- Sponsor
- HealthPartners Institute · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Apr 2010
- Primary completion
- May 2013
- Completion
- May 2013
- First posted
- 18 Mar 2010 (estimated)
- Last update posted
- 23 May 2017
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20102011201220132014
- N/A
Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
NCT01089569Apr 2010 to May 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ExenatideDrug
- Insulin GlargineDrug
Arms3
Active comparator
Exenatide
5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
Active comparator
Insulin Glargine
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Active comparator
Exenatide + Insulin Glargine
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study \+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Primary outcomes1
Outcomes the sponsor listed as primary.
HbA1c Change
Time frame · baseline to final visit (32 weeks)
Registry description
Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination. Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.
Secondary outcomes(6)
Change From Baseline in Incidence of Hypoglycemia (Frequency)
Time frame · baseline to final visit (32 weeks)
Registry description
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (frequency) Change from baseline was calculated as mean incidence rate at baseline minus mean incidence rate at final visit (32 weeks)
Change From Baseline in Incidence of Hypoglycemia (Degree)
Time frame · baseline to final visit (32 weeks)
Registry description
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (degree) Change from baseline was calculated as mean incidence percentage at baseline minus mean incidence percentage at final visit (32 weeks)
Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)
Time frame · baseline to final visit (32 weeks)
Registry description
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves iii. Glucose stability (absolute hourly rate of change in median curve) Change from baseline was calculated as mean absolute hourly rate of change in median curve at baseline minus rate at final visit (32 weeks). Mean absolute hourly rate of change in the smoothed median curve is calculated as delta subscript MC = (\|p subscript 50 zero - p subscript 50 23\|+Sum superscript 23 subscript i = 1\| p subscript 50i - p subscript 50 i-1\| over T. i = hour of day p subscript 50i = smoothed 50th percentile value for ith hour of day T = total # of non-missing hourly smoothed percentiles
Change From Baseline in CGM Glucose Variability
Time frame · baseline to final visit (32 weeks)
Registry description
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- ii. Glucose variability (inter-quartile range) IQR is the difference between the 75th and 25th percentiles. Change from baseline was calculated as IQR at baseline minus IQR value at final visit (32 weeks).
Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)
Time frame · baseline - final visit (32 weeks)
Registry description
Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) Change from baseline was calculated as area under the diurnal median curve at baseline minus AUC value at final visit (32 weeks). AUC is calculated using modified rectangle method AUC = sum of superscript 23, subscript i=0 P subscript 50i I = hour of day P subscript 50i = smoother 50th percentile value for ith hour of day
Change From Baseline in Weight Changes
Time frame · baseline - final visit (32 weeks)
Registry description
Measure the changes in weight attributable to exenatide, insulin glargine and their combinations. Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin. Change from baseline was calculated as weight in pounds at baseline minus weight in pounds at final visit (32 weeks).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· baseline to final visit (32 weeks)
Change From Baseline in Incidence of Hypoglycemia (Frequency)
| Group | Value (episodes/day) | Spread |
|---|---|---|
| Exenatide | .7 | 0.8 |
| Insulin Glargine | .8 | 0.8 |
| Exenatide + Insulin Glargine | .6 | 0.4 |
Secondary outcomeMean· baseline to final visit (32 weeks)
Change From Baseline in Incidence of Hypoglycemia (Degree)
| Group | Value (percentage of measures under 70 mg/dL) | Spread |
|---|---|---|
| Exenatide | 1.7 | 2.7 |
| Insulin Glargine | 1.7 | 1.8 |
| Exenatide + Insulin Glargine | 1.3 | 1.1 |
Secondary outcomeMean· baseline to final visit (32 weeks)
Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)
| Group | Value (mg/dL/hr) | Spread |
|---|---|---|
| Exenatide | -2 | 2.7 |
| Insulin Glargine | -2.9 | 4.4 |
| Exenatide + Insulin Glargine | -2 | 3.5 |
Secondary outcomeMean· baseline to final visit (32 weeks)
Change From Baseline in CGM Glucose Variability
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide | -9 | 9.1 |
| Insulin Glargine | -7.7 | 19.4 |
| Exenatide + Insulin Glargine | -12.1 | 14 |
Secondary outcomeMean· baseline - final visit (32 weeks)
Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)
| Group | Value (mg/dL*24hr) | Spread |
|---|---|---|
| Exenatide | -1207.1 | 661.1 |
| Insulin Glargine | -1476.2 | 849.2 |
| Exenatide + Insulin Glargine | -1315 | 953.9 |
Secondary outcomeMean· baseline - final visit (32 weeks)
Change From Baseline in Weight Changes
| Group | Value (lbs (pounds)) | Spread |
|---|---|---|
| Exenatide | -13.5 | 10.2 |
| Insulin Glargine | -0.5 | 7.7 |
| Exenatide + Insulin Glargine | -10.3 | 10.5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study Exenatide: refer to Arm detail | – | 0 / 20 | 20 / 20 |
| Insulin Glargine.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results Insulin Glargine: refer to Arm detail | – | 0 / 20 | 10 / 20 |
| Exenatide + Insulin GlargineExenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study \+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results | – | 0 / 20 | 13 / 20 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Clinical trial · 2009
7 results
Diurnal glucose patterns of exenatide once weekly: a 1-year study using continuous glucose monitoring with ambulatory glucose profile analysis.
Mazze et al. 2009Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 20
PMID 19454385DOI 10.4158/ep09046.orrPUB-19454385
Full text at the publisher7 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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) \<30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
* ALT(Alanine Transaminase) \> 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
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