Trial Outcomes & Findings for Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes (NCT NCT01060059)

NCT ID: NCT01060059

Last Updated: 2015-04-09

Results Overview

Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.

• Recruitment status: COMPLETED
• Target enrollment: 888 participants
• Primary outcome timeframe: Baseline, Month 12
• Results posted on: 2015-04-09

Participant Flow

Six patients were not assigned to any cohort because the type of treatment taken was not reported.

Participant milestones

Measure	Exenatide The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Overall Study STARTED	444	438
Overall Study COMPLETED	377	371
Overall Study NOT COMPLETED	67	67

Reasons for withdrawal

Measure	Exenatide The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Overall Study Adverse Event	1	1
Overall Study Death	2	3
Overall Study Lost to Follow-up	18	34
Overall Study entry criteria not met	4	3
Overall Study Withdrawal by Subject	35	23
Overall Study lack of glycemic control	2	1
Overall Study lack of compliance	5	2

Baseline Characteristics

Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment	Total n=882 Participants Total of all reporting groups
Age, Continuous	59.2 years STANDARD_DEVIATION 9.65 • n=93 Participants	65.9 years STANDARD_DEVIATION 9.62 • n=4 Participants	62.5 years STANDARD_DEVIATION 10.19 • n=27 Participants
Sex: Female, Male Female	198 Participants n=93 Participants	191 Participants n=4 Participants	389 Participants n=27 Participants
Sex: Female, Male Male	246 Participants n=93 Participants	247 Participants n=4 Participants	493 Participants n=27 Participants
Weight	97.5 kg STANDARD_DEVIATION 21.39 • n=93 Participants	79.5 kg STANDARD_DEVIATION 15.82 • n=4 Participants	88.6 kg STANDARD_DEVIATION 20.91 • n=27 Participants
Glycosylated hemoglobin (HbA1c)	8.7 percent STANDARD_DEVIATION 1.34 • n=93 Participants	9.2 percent STANDARD_DEVIATION 1.40 • n=4 Participants	8.9 percent STANDARD_DEVIATION 1.39 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.

Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.

Outcome measures

Measure	Exenatide n=397 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=405 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.	35.0 percentage of patients Interval 30.32 to 39.93	15.8 percentage of patients Interval 12.39 to 19.73

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.

Changes in HbA1c from Baseline to Month 12

Outcome measures

Measure	Exenatide n=379 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=364 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in HbA1c From Baseline to Month 12	-1.1 percent Standard Deviation 1.40	-1.4 percent Standard Deviation 1.49

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.

Changes in Fasting Blood Glucose From Baseline to Month 12

Outcome measures

Measure	Exenatide n=303 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=287 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in Fasting Blood Glucose From Baseline to Month 12	-26.7 mg/dL Standard Deviation 57.05	-51.4 mg/dL Standard Deviation 64.53

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Percentage of Patients with HbA1c Reduction from Baseline >= 1.0% at Month 12

Outcome measures

Measure	Exenatide n=397 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=405 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12	49.4 percentage of patients	51.1 percentage of patients

SECONDARY outcome

Timeframe: Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12

Outcome measures

Measure	Exenatide n=397 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=405 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12	39.0 percentage of patients	22.2 percentage of patients

SECONDARY outcome

Timeframe: Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12

Outcome measures

Measure	Exenatide n=397 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=405 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12	13.1 percentage of patients	4.9 percentage of patients

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Changes in Weight From Baseline to Month 12

Outcome measures

Measure	Exenatide n=377 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=366 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in Weight From Baseline to Month 12	-3.9 kg Standard Deviation 5.92	0.2 kg Standard Deviation 4.78

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Percentage of Patients Achieving a Weight Decrease >=3% between Baseline and Month 12

Outcome measures

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12	43.0 percentage of patients	17.6 percentage of patients

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Percentage of Patients Achieving a Weight Decrease >=5% between Baseline and Month 12

Outcome measures

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12	29.7 percentage of patients	10.7 percentage of patients

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Changes in Fasting Total Cholesterol Between Baseline and Month 12

Outcome measures

Measure	Exenatide n=249 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=225 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in Fasting Total Cholesterol Between Baseline and Month 12	-6.0 mg/dL Standard Deviation 36.22	-7.5 mg/dL Standard Deviation 43.58

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Changes in Fasting HDL Between Baseline and Month 12

Outcome measures

Measure	Exenatide n=226 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=203 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in Fasting HDL Between Baseline and Month 12	1.3 mg/dL Standard Deviation 10.12	0.2 mg/dL Standard Deviation 10.18

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Changes in Fasting LDL Between Baseline and Month 12

Outcome measures

Measure	Exenatide n=164 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=138 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in Fasting LDL Between Baseline and Month 12	-4.6 mg/dL Standard Deviation 30.79	-4.5 mg/dL Standard Deviation 38.35

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Changes in Fasting Triglycerides Between Baseline and Month 12

Outcome measures

Measure	Exenatide n=240 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=226 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in Fasting Triglycerides Between Baseline and Month 12	-16.5 mg/dL Standard Deviation 115.27	-30.2 mg/dL Standard Deviation 108.15

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Changes in Diastolic Blood Pressure Between Baseline and Month 12

Outcome measures

Measure	Exenatide n=369 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=360 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in Diastolic Blood Pressure Between Baseline and Month 12	-2.4 mmHg Standard Deviation 10.40	0.2 mmHg Standard Deviation 10.20

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Changes in Systolic Blood Pressure Between Baseline and Month 12

Outcome measures

Measure	Exenatide n=369 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=360 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Changes in Systolic Blood Pressure Between Baseline and Month 12	-4.6 mmHg Standard Deviation 18.74	-1.0 mmHg Standard Deviation 17.56

SECONDARY outcome

Timeframe: Baseline to Month 12

Population: All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes

Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12.

All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.

Outcome measures

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12	3.6 percentage of patients	8.2 percentage of patients

SECONDARY outcome

Timeframe: baseline

Population: All patients consented to release information; fulfilled study entry criteria. Analyses conducted on baseline arm assignment, irrespective of later treatment changes. Only those assigned to an arm were included. Missing values for numeric covariates replaced with means; categorical ones, with modes.

Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.

Outcome measures

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline Male Gender	246 participants Interval 0.62 to 1.46	247 participants
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline Female Gender	198 participants	191 participants
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline Medical conditions present	371 participants Interval 0.74 to 1.76	363 participants
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline No medical conditions	73 participants	75 participants
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline Previous gastrointestinal symptoms present	8 participants Interval 0.43 to 3.42	11 participants
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline No gastrointestinal symptoms	436 participants	427 participants

SECONDARY outcome

Timeframe: baseline

Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FAS=444, however 1 patient in the exenatide arm was missing data for the most recent HbA1c at baseline so n=443.

Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).

Outcome measures

Measure	Exenatide n=443 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline	8.7 Percentage of normal Standard Deviation 1.34	9.2 Percentage of normal Standard Deviation 1.40

SECONDARY outcome

Timeframe: baseline

Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.

The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.

Outcome measures

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline	9.0 years Standard Deviation 7.03	12.4 years Standard Deviation 8.29

SECONDARY outcome

Timeframe: baseline

Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.

Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.

Outcome measures

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Factor of Older Age Associated With Treatment Choice at Baseline	59.2 years Standard Deviation 9.65	65.9 years Standard Deviation 9.62

SECONDARY outcome

Timeframe: baseline

Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FAS for basal insulin arm=438 but one patient did not have data in this arm so n=437.

Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m^2.

Outcome measures

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=437 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline	35.4 kg/m^2 Standard Deviation 6.83	29.4 kg/m^2 Standard Deviation 5.12

SECONDARY outcome

Timeframe: baseline

Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FAS for basal insulin arm=438 but one patient did not provide height data so n=437.

Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .

Outcome measures

Measure	Exenatide n=444 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=437 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Factor of Greater Height Associated With Treatment Choice at Baseline	165.8 cm Standard Deviation 9.56	164.4 cm Standard Deviation 9.10

SECONDARY outcome

Timeframe: baseline

Population: Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FASS=444 and 438 in each arm respectively but the number of patients with creatinine and fasting lipids data at baseline varied. N is presented with each category.

Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).

Outcome measures

Measure	Exenatide n=368 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=360 Participants The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
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 Creatinine (N=324, 333)	0.9 mg/dL Standard Deviation 0.24	1.0 mg/dL Standard Deviation 0.39
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 HDL (N=335, 326)	44.7 mg/dL Standard Deviation 12.82	46.9 mg/dL Standard Deviation 12.31
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 Total Cholesterol (N=368, 355)	181.1 mg/dL Standard Deviation 40.00	182.7 mg/dL Standard Deviation 41.79
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 Triglycerides (N=364, 360)	177.5 mg/dL Standard Deviation 112.57	173.6 mg/dL Standard Deviation 104.24

Adverse Events

Exenatide

Serious events: 11 serious events

Other events: 19 other events

Deaths: 0 deaths

Basal Insulin

Serious events: 10 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exenatide n=444 participants at risk The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 participants at risk The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/444	0.23% 1/438 • Number of events 1
Cardiac disorders Atrial fibrillation	0.23% 1/444 • Number of events 1	0.00% 0/438
Cardiac disorders Cardiac failure	0.00% 0/444	0.46% 2/438 • Number of events 2
Cardiac disorders Coronary artery disease	0.23% 1/444 • Number of events 1	0.00% 0/438
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/444	0.46% 2/438 • Number of events 2
Cardiac disorders Myocardial infarction	0.45% 2/444 • Number of events 2	0.23% 1/438 • Number of events 1
Ear and labyrinth disorders Vertigo positional	0.23% 1/444 • Number of events 1	0.00% 0/438
Gastrointestinal disorders Duodenal ulcer	0.00% 0/444	0.23% 1/438 • Number of events 1
Gastrointestinal disorders Pancreatitis haemorrhagic	0.23% 1/444 • Number of events 1	0.00% 0/438
Hepatobiliary disorders Cholelithiasis	0.23% 1/444 • Number of events 1	0.00% 0/438
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.23% 1/444 • Number of events 1	0.00% 0/438
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/444	0.23% 1/438 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.23% 1/444 • Number of events 1	0.00% 0/438
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.23% 1/444 • Number of events 1	0.00% 0/438
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.23% 1/444 • Number of events 1	0.00% 0/438
Nervous system disorders Carotid artery stenosis	0.00% 0/444	0.23% 1/438 • Number of events 1
Nervous system disorders Cerebrovascular accident	0.00% 0/444	0.23% 1/438 • Number of events 1
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/444	0.23% 1/438 • Number of events 2
Nervous system disorders Coma hepatic	0.00% 0/444	0.23% 1/438 • Number of events 1
Renal and urinary disorders Urinary tract inflammation	0.00% 0/444	0.23% 1/438 • Number of events 1
Reproductive system and breast disorders Benign prostatic hyperplasia	0.23% 1/444 • Number of events 1	0.00% 0/438
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/444	0.23% 1/438 • Number of events 1

Other adverse events

Measure	Exenatide n=444 participants at risk The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day	Basal Insulin n=438 participants at risk The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
Eye disorders Diabetic retinopathy	0.00% 0/444	0.23% 1/438 • Number of events 1
Gastrointestinal disorders Diarrhoea	0.68% 3/444 • Number of events 3	0.46% 2/438 • Number of events 4
Gastrointestinal disorders Dyspepsia	0.23% 1/444 • Number of events 1	0.00% 0/438
Gastrointestinal disorders Pancreatitis	0.23% 1/444 • Number of events 1	0.00% 0/438
General disorders Chest pain	0.23% 1/444 • Number of events 1	0.00% 0/438
Infections and infestations Bronchitis	0.23% 1/444 • Number of events 1	0.00% 0/438
Infections and infestations Herpes zoster	0.00% 0/444	0.23% 1/438 • Number of events 1
Infections and infestations Lung infection	0.00% 0/444	0.23% 1/438 • Number of events 1
Injury, poisoning and procedural complications Hand fracture	0.23% 1/444 • Number of events 1	0.00% 0/438
Investigations Gamma-glutamyltransferase increased	0.00% 0/444	0.23% 1/438 • Number of events 1
Investigations Lipase increased	0.23% 1/444 • Number of events 1	0.00% 0/438
Metabolism and nutrition disorders Dehydration	0.23% 1/444 • Number of events 1	0.00% 0/438
Metabolism and nutrition disorders Hyperamylasaemia	0.68% 3/444 • Number of events 4	0.00% 0/438
Metabolism and nutrition disorders Hyperglycaemia	0.23% 1/444 • Number of events 1	0.00% 0/438
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/444	0.23% 1/438 • Number of events 1
Metabolism and nutrition disorders Hyperlipasaemia	0.68% 3/444 • Number of events 4	0.00% 0/438
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/444	0.23% 1/438 • Number of events 1
Musculoskeletal and connective tissue disorders Osteoarthritis	0.23% 1/444 • Number of events 2	0.00% 0/438
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/444	0.23% 1/438 • Number of events 1
Nervous system disorders Carotid artery stenosis	0.23% 1/444 • Number of events 1	0.00% 0/438
Nervous system disorders Headache	0.45% 2/444 • Number of events 2	0.23% 1/438 • Number of events 1
Renal and urinary disorders Haematuria	0.23% 1/444 • Number of events 1	0.00% 0/438
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.23% 1/444 • Number of events 1	0.00% 0/438
Skin and subcutaneous tissue disorders Skin exfoliation	0.23% 1/444 • Number of events 1	0.00% 0/438
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/444	0.23% 1/438 • Number of events 1
Surgical and medical procedures Hospitalisation	0.23% 1/444 • Number of events 2	0.00% 0/438

Additional Information

Peter Ohman, Medical Science Director

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place