Primary outcomeLeast squares mean· Baseline to 20 Weeks
Change in HbA1c (Percent)
| Group | Value (Percent HbA1c) | Spread |
|---|---|---|
| Exenatide + Placebo | -0.38 | 0.09 |
| Exenatide + Sitagliptin | -0.68 | 0.08 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataA Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
NCTNCT00870194 (opens ClinicalTrials.gov in a new tab)Other idH8O-CR-GWDK
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 255 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Double masking
- Countries
7 countries
Argentina, Australia, Germany, Greece, India, Mexico, South Korea
- Start
- Mar 2009
- Primary completion
- Apr 2010
- Completion
- Apr 2010
- First posted
- 27 Mar 2009 (estimated)
- Last update posted
- 9 Apr 2015 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200920102011
- Ph 4
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
NCT00870194Mar 2009 to Apr 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- exenatide and sitagliptinDrug
- exenatide and placeboDrug
Arms2
Experimental
1
Placebo comparator
2
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c (Percent)
Time frame · Baseline to 20 Weeks
Registry description
Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values \[X% - Y%\]
Secondary outcomes(16)
Percentage of Patients Achieving HbA1c <=7.0%
Time frame · Baseline to 20 Weeks
Registry description
Percentage of patients whose baseline HbA1c was \> 7.0% achieving HbA1c \<=7.0% at endpoint (Week 20)
Percentage of Patients Achieving HbA1c <7.0%
Time frame · Baseline to 20 Weeks
Registry description
Percentage of patients whose baseline HbA1c was \>=7.0% achieving HbA1c \<7.0% at endpoint (Week 20)
Percentage of Patients Achieving HbA1c <=6.5%
Time frame · Baseline to 20 Weeks
Registry description
Percentage of patients whose baseline HbA1c was \> 6.5% achieving HbA1c \<=6.5% at endpoint (Week 20)
Change in FSG (mmol/L)
Time frame · Baseline to 20 Weeks
Registry description
Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
Change in Body Weight (kg)
Time frame · Baseline to 20 Weeks
Registry description
Change in body weight from baseline to endpoint (Week 20)
Change in Waist Circumference (cm)
Time frame · Baseline to 20 Weeks
Registry description
Change in waist circumference from baseline to endpoint (Week 20)
Waist-to-Hip Ratio
Time frame · Baseline to 20 Weeks
Registry description
Change in waist-to-hip ratio from baseline to endpoint (Week20)
SMBG (mmol/L)
Time frame · Baseline to 20 Weeks
Registry description
7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)
Change in Triglycerides (mmol/L)
Time frame · Baseline to 20 Weeks
Registry description
Change in triglycerides from baseline to endpoint (Week 20)
Change in HDL (mmol/L)
Time frame · Baseline to 20 Weeks
Registry description
Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
Change in LDL (mmol/L)
Time frame · Baseline to 20 Weeks
Registry description
Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
Change in Total Cholesterol (mmol/L)
Time frame · Baseline to 20 Weeks
Registry description
Change in total cholesterol from baseline to endpoint (Week 20)
Incidence of Hypoglycemia (Overall)
Time frame · Baseline to 20 Weeks
Registry description
Incidence of hypoglycemic episodes experienced overall during the study
Incidence of Severe Hypoglycemia(Overall)
Time frame · Baseline to 20 Weeks
Registry description
Incidence of severe hypoglycemia experienced overall during the study
Incidence of Nocturnal Hypoglycemia (Overall)
Time frame · Baseline to 20 Weeks
Registry description
Incidence of nocturnal hypoglycemia experienced overall during the study
Incidence of Confirmed Hypoglycemia(Overall)
Time frame · Baseline to 20 Weeks
Registry description
Incidence of confirmed hypoglycemia experienced overall during the study
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(7)
Secondary outcomeNumber· Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <=7.0%
| Group | Value (Percentage) |
|---|---|
| Exenatide + Placebo | 29.5 |
| Exenatide + Sitagliptin | 44.3 |
Secondary outcomeNumber· Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <7.0%
| Group | Value (Percentage) |
|---|---|
| Exenatide + Placebo | 26.6 |
| Exenatide + Sitagliptin | 41.7 |
Secondary outcomeNumber· Baseline to 20 Weeks
Percentage of Patients Achieving HbA1c <=6.5%
| Group | Value (Percentage) |
|---|---|
| Exenatide + Placebo | 16.5 |
| Exenatide + Sitagliptin | 20.7 |
Secondary outcomeLeast squares mean· Baseline to 20 Weeks
Change in FSG (mmol/L)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide + Placebo | 0.06 | 0.23 |
| Exenatide + Sitagliptin | -0.55 | 0.21 |
Secondary outcomeLeast squares mean· Baseline to 20 Weeks
Change in Body Weight (kg)
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide + Placebo | -2.58 | 0.25 |
| Exenatide + Sitagliptin | -2.20 | 0.24 |
Secondary outcomeLeast squares mean· Baseline to 20 Weeks
Change in Waist Circumference (cm)
| Group | Value (cm) | Spread |
|---|---|---|
| Exenatide + Placebo | -3.25 | 0.40 |
| Exenatide + Sitagliptin | -2.36 | 0.37 |
Secondary outcomeLeast squares mean· Baseline to 20 Weeks
Waist-to-Hip Ratio
| Group | Value (Ratio) | Spread |
|---|---|---|
| Exenatide + Placebo | -0.01 | 0.00 |
| Exenatide + Sitagliptin | -0.00 | 0.00 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide + PlaceboExenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day. | – | 4 / 127 | 36 / 127 |
| Exenatide + SitagliptinExenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day. | – | 6 / 128 | 28 / 128 |
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: Randomized controlled trial · 2012
7 results
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.
Violante et al. 2012Diabetic medicine : a journal of the British Diabetic Associationcited by 31
PMID 22375612DOI 10.1111/j.1464-5491.2012.03624.xPUB-22375612
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:
* 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
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.
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