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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00870194
Ethics application status
Date submitted
25/03/2009
Date registered
27/03/2009
Date last updated
9/04/2015

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
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

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

Outcomes
Primary outcome [1] 0 0
Change in HbA1c (Percent)
Timepoint [1] 0 0
Baseline to 20 Weeks
Secondary outcome [1] 0 0
Percentage of Patients Achieving HbA1c <=7.0%
Timepoint [1] 0 0
Baseline to 20 Weeks
Secondary outcome [2] 0 0
Percentage of Patients Achieving HbA1c <7.0%
Timepoint [2] 0 0
Baseline to 20 Weeks
Secondary outcome [3] 0 0
Percentage of Patients Achieving HbA1c <=6.5%
Timepoint [3] 0 0
Baseline to 20 Weeks
Secondary outcome [4] 0 0
Change in FSG (mmol/L)
Timepoint [4] 0 0
Baseline to 20 Weeks
Secondary outcome [5] 0 0
Change in Body Weight (kg)
Timepoint [5] 0 0
Baseline to 20 Weeks
Secondary outcome [6] 0 0
Change in Waist Circumference (cm)
Timepoint [6] 0 0
Baseline to 20 Weeks
Secondary outcome [7] 0 0
Waist-to-Hip Ratio
Timepoint [7] 0 0
Baseline to 20 Weeks
Secondary outcome [8] 0 0
SMBG (mmol/L)
Timepoint [8] 0 0
Baseline to 20 Weeks
Secondary outcome [9] 0 0
Change in Triglycerides (mmol/L)
Timepoint [9] 0 0
Baseline to 20 Weeks
Secondary outcome [10] 0 0
Change in HDL (mmol/L)
Timepoint [10] 0 0
Baseline to 20 Weeks
Secondary outcome [11] 0 0
Change in LDL (mmol/L)
Timepoint [11] 0 0
Baseline to 20 Weeks
Secondary outcome [12] 0 0
Change in Total Cholesterol (mmol/L)
Timepoint [12] 0 0
Baseline to 20 Weeks
Secondary outcome [13] 0 0
Incidence of Hypoglycemia (Overall)
Timepoint [13] 0 0
Baseline to 20 Weeks
Secondary outcome [14] 0 0
Incidence of Severe Hypoglycemia(Overall)
Timepoint [14] 0 0
Baseline to 20 Weeks
Secondary outcome [15] 0 0
Incidence of Nocturnal Hypoglycemia (Overall)
Timepoint [15] 0 0
Baseline to 20 Weeks
Secondary outcome [16] 0 0
Incidence of Confirmed Hypoglycemia(Overall)
Timepoint [16] 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
Sex
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
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
255
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

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/study/NCT00870194
Trial related presentations / publications
Violante R, Oliveira JH, Yoon KH, Reed VA, Yu MB, Bachmann OP, Ludemann J, Chan JY. A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitagliptin. Diabet Med. 2012 Nov;29(11):e417-24. doi: 10.1111/j.1464-5491.2012.03624.x.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00870194