Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Wednesday 29th May for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00870194




Registration number
NCT00870194
Ethics application status
Date submitted
25/03/2009
Date registered
26/03/2009
Date last updated
20/03/2015

Titles & IDs
Public title
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
Scientific title
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
Secondary ID [1] 0 0
H8O-CR-GWDK
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - exenatide and sitagliptin
Treatment: Drugs - exenatide and placebo
Treatment: Drugs - exenatide and sitagliptin
Treatment: Drugs - exenatide and placebo

Experimental: 1 -

Placebo Comparator: 2 -

Experimental: 1 -

Placebo Comparator: 2 -


Treatment: Drugs: exenatide and sitagliptin
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day

Treatment: Drugs: exenatide and placebo
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day

Treatment: Drugs: exenatide and sitagliptin
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day

Treatment: Drugs: exenatide and placebo
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c (Percent) - Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]
Timepoint [1] 0 0
Baseline to 20 Weeks
Primary outcome [2] 0 0
Change in HbA1c (Percent) - Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]
Timepoint [2] 0 0
Baseline to 20 Weeks
Secondary outcome [1] 0 0
Percentage of Patients Achieving HbA1c <=7.0% - Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)
Timepoint [1] 0 0
Baseline to 20 Weeks
Secondary outcome [2] 0 0
Percentage of Patients Achieving HbA1c <7.0% - Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)
Timepoint [2] 0 0
Baseline to 20 Weeks
Secondary outcome [3] 0 0
Percentage of Patients Achieving HbA1c <=6.5% - Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)
Timepoint [3] 0 0
Baseline to 20 Weeks
Secondary outcome [4] 0 0
Change in FSG (mmol/L) - Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
Timepoint [4] 0 0
Baseline to 20 Weeks
Secondary outcome [5] 0 0
Change in Body Weight (kg) - Change in body weight from baseline to endpoint (Week 20)
Timepoint [5] 0 0
Baseline to 20 Weeks
Secondary outcome [6] 0 0
Change in Waist Circumference (cm) - Change in waist circumference from baseline to endpoint (Week 20)
Timepoint [6] 0 0
Baseline to 20 Weeks
Secondary outcome [7] 0 0
Waist-to-Hip Ratio - Change in waist-to-hip ratio from baseline to endpoint (Week20)
Timepoint [7] 0 0
Baseline to 20 Weeks
Secondary outcome [8] 0 0
SMBG (mmol/L) - 7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)
Timepoint [8] 0 0
Baseline to 20 Weeks
Secondary outcome [9] 0 0
Change in Triglycerides (mmol/L) - Change in triglycerides from baseline to endpoint (Week 20)
Timepoint [9] 0 0
Baseline to 20 Weeks
Secondary outcome [10] 0 0
Change in HDL (mmol/L) - Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
Timepoint [10] 0 0
Baseline to 20 Weeks
Secondary outcome [11] 0 0
Change in LDL (mmol/L) - Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
Timepoint [11] 0 0
Baseline to 20 Weeks
Secondary outcome [12] 0 0
Change in Total Cholesterol (mmol/L) - Change in total cholesterol from baseline to endpoint (Week 20)
Timepoint [12] 0 0
Baseline to 20 Weeks
Secondary outcome [13] 0 0
Incidence of Hypoglycemia (Overall) - Incidence of hypoglycemic episodes experienced overall during the study
Timepoint [13] 0 0
Baseline to 20 Weeks
Secondary outcome [14] 0 0
Incidence of Severe Hypoglycemia(Overall) - Incidence of severe hypoglycemia experienced overall during the study
Timepoint [14] 0 0
Baseline to 20 Weeks
Secondary outcome [15] 0 0
Incidence of Nocturnal Hypoglycemia (Overall) - Incidence of nocturnal hypoglycemia experienced overall during the study
Timepoint [15] 0 0
Baseline to 20 Weeks
Secondary outcome [16] 0 0
Incidence of Confirmed Hypoglycemia(Overall) - Incidence of confirmed hypoglycemia experienced overall during the study
Timepoint [16] 0 0
Baseline to 20 Weeks
Secondary outcome [17] 0 0
Percentage of Patients Achieving HbA1c <=7.0% - Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)
Timepoint [17] 0 0
Baseline to 20 Weeks
Secondary outcome [18] 0 0
Percentage of Patients Achieving HbA1c <7.0% - Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)
Timepoint [18] 0 0
Baseline to 20 Weeks
Secondary outcome [19] 0 0
Percentage of Patients Achieving HbA1c <=6.5% - Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)
Timepoint [19] 0 0
Baseline to 20 Weeks
Secondary outcome [20] 0 0
Change in FSG (mmol/L) - Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
Timepoint [20] 0 0
Baseline to 20 Weeks
Secondary outcome [21] 0 0
Change in Body Weight (kg) - Change in body weight from baseline to endpoint (Week 20)
Timepoint [21] 0 0
Baseline to 20 Weeks
Secondary outcome [22] 0 0
Change in Waist Circumference (cm) - Change in waist circumference from baseline to endpoint (Week 20)
Timepoint [22] 0 0
Baseline to 20 Weeks
Secondary outcome [23] 0 0
Waist-to-Hip Ratio - Change in waist-to-hip ratio from baseline to endpoint (Week20)
Timepoint [23] 0 0
Baseline to 20 Weeks
Secondary outcome [24] 0 0
SMBG (mmol/L) - 7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)
Timepoint [24] 0 0
Baseline to 20 Weeks
Secondary outcome [25] 0 0
Change in Triglycerides (mmol/L) - Change in triglycerides from baseline to endpoint (Week 20)
Timepoint [25] 0 0
Baseline to 20 Weeks
Secondary outcome [26] 0 0
Change in HDL (mmol/L) - Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
Timepoint [26] 0 0
Baseline to 20 Weeks
Secondary outcome [27] 0 0
Change in LDL (mmol/L) - Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
Timepoint [27] 0 0
Baseline to 20 Weeks
Secondary outcome [28] 0 0
Change in Total Cholesterol (mmol/L) - Change in total cholesterol from baseline to endpoint (Week 20)
Timepoint [28] 0 0
Baseline to 20 Weeks
Secondary outcome [29] 0 0
Incidence of Hypoglycemia (Overall) - Incidence of hypoglycemic episodes experienced overall during the study
Timepoint [29] 0 0
Baseline to 20 Weeks
Secondary outcome [30] 0 0
Incidence of Severe Hypoglycemia(Overall) - Incidence of severe hypoglycemia experienced overall during the study
Timepoint [30] 0 0
Baseline to 20 Weeks
Secondary outcome [31] 0 0
Incidence of Nocturnal Hypoglycemia (Overall) - Incidence of nocturnal hypoglycemia experienced overall during the study
Timepoint [31] 0 0
Baseline to 20 Weeks
Secondary outcome [32] 0 0
Incidence of Confirmed Hypoglycemia(Overall) - Incidence of confirmed hypoglycemia experienced overall during the study
Timepoint [32] 0 0
Baseline to 20 Weeks

Eligibility
Key inclusion criteria
- Present with type 2 diabetes

- Patients have been treated with a stable dose of the following for at least 3 months
prior to screening:

- 100 mg/day sitagliptin and

- =1500 mg/day metformin, or maximum tolerated dose (extended release or
immediate-release).

- Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%,
inclusive.

- Have a body mass index (BMI) =20 kg/m2 and <45 kg/m2
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Are currently enrolled in, or discontinued within the last 30 days (or longer, if
local guidelines require) from, a clinical trial involving an off-label use of an
investigational drug or device, or concurrently enrolled in any other type of medical
research judged not to be scientifically or medically compatible with this study.

- Have previously completed or withdrawn from this study or any other study
investigating exenatide.

- Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients
contained in exenatide or sitagliptin.

- Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine,
or similar over-the-counter medications) within 1 month of screening.

- Are currently treated with any of the following excluded medications:

- Thiazolidinediones (TZD) within 3 months of screening.

- Sulfonylurea (SU) within 3 months of screening.

- Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin,
within 3 months of screening.

- Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months
of screening.

- Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months
of screening.

- Exogenous insulin within the 3 months prior to screening.

- Drugs that directly affect gastrointestinal motility, including, but not limited
to: metoclopramide, cisapride, and chronic macrolide antibiotics.

- Systemic corticosteroids (excluding topical and inhaled preparations) by oral,
intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1
month) or used within 1 month immediately prior to screening.

- Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin,
within 3 months prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Geelong
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Geelong
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Morón
Country [3] 0 0
Germany
State/province [3] 0 0
Aschaffenburg
Country [4] 0 0
Germany
State/province [4] 0 0
Asslar
Country [5] 0 0
Germany
State/province [5] 0 0
Beckum-Neubeckum
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Bosenheim
Country [8] 0 0
Germany
State/province [8] 0 0
Essen
Country [9] 0 0
Germany
State/province [9] 0 0
Falkensee
Country [10] 0 0
Germany
State/province [10] 0 0
Furth im Wald
Country [11] 0 0
Germany
State/province [11] 0 0
Grevenbroich
Country [12] 0 0
Germany
State/province [12] 0 0
Hamburg-Othmarschen
Country [13] 0 0
Germany
State/province [13] 0 0
Hohenmolsen
Country [14] 0 0
Germany
State/province [14] 0 0
Leipzig
Country [15] 0 0
Germany
State/province [15] 0 0
Neuwied
Country [16] 0 0
Germany
State/province [16] 0 0
Pohlheim
Country [17] 0 0
Germany
State/province [17] 0 0
Speyer
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Greece
State/province [19] 0 0
Thessaloniki
Country [20] 0 0
India
State/province [20] 0 0
Ahmedabad
Country [21] 0 0
India
State/province [21] 0 0
Bangalore
Country [22] 0 0
India
State/province [22] 0 0
Coimbatore
Country [23] 0 0
India
State/province [23] 0 0
Indore
Country [24] 0 0
India
State/province [24] 0 0
Jaipur
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Daegu
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Gwangju
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Ulsan
Country [29] 0 0
Mexico
State/province [29] 0 0
Coatzacoalcos
Country [30] 0 0
Mexico
State/province [30] 0 0
Guadalajara
Country [31] 0 0
Mexico
State/province [31] 0 0
Merida
Country [32] 0 0
Mexico
State/province [32] 0 0
Monterrey
Country [33] 0 0
Mexico
State/province [33] 0 0
Tampico

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Eli Lilly and Company
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether ceasing sitagliptin and switching to
exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in
those patients with type 2 diabetes who are experiencing inadequate glycemic control with a
combination of sitagliptin and metformin.
Trial website
https://clinicaltrials.gov/show/NCT00870194
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chief Medical Officer, MD
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications