Primary outcomeLeast squares mean· Baseline to Week 28
Change in HbA1c From Baseline to Week 28
| Group | Value (Percentage of HbA1c) |
|---|---|
| Exenatide | -0.96 |
| Placebo | -0.22 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataPhase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
NCTNCT02229383 (opens ClinicalTrials.gov in a new tab)Other idD5553C00002Other id2014-003502-33Other id2014
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 464 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Double masking
- Countries
6 countries
United States, Hungary, Poland, Romania, Slovakia, South Africa
- Start
- 6 Sept 2014
- Primary completion
- 29 Aug 2016
- Completion
- 29 Aug 2016
- First posted
- 1 Sept 2014 (estimated)
- Last update posted
- 8 Jan 2019
- Conditions
- Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2014201520162017
- Ph 3
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
NCT022293836 Sept 2014 to 29 Aug 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.
Interventions
- ExenatideDrug
- Exenatide matching placeboDrug
Arms2
Experimental
Exenatide
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Placebo comparator
Placebo
Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.
Secondary outcomes(6)
Change in Body Weight From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)
Time frame · Baseline to Week 28
Registry description
To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Percentage of Participants Achieving HbA1c <7.0% at Week 28
Time frame · Baseline to Week 28
Registry description
To compare the percentage of participants achieving HbA1c \<7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Change From Baseline to Week 28 in Daily Insulin Dose
Time frame · Baseline to Week 28
Registry description
To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks
Time frame · Baseline to Week 28
Registry description
To compare the percentage of participants achieving HbA1c \<7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.
Change in Seated Systolic Blood Pressure From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
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 outcomeLeast squares mean· Baseline to Week 28
Change in Body Weight From Baseline to Week 28
| Group | Value (kilogram) |
|---|---|
| Exenatide | -1.04 |
| Placebo | 0.48 |
Secondary outcomeLeast squares mean· Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)
| Group | Value (milligram per deciliter) |
|---|---|
| Exenatide | -28.73 |
| Placebo | -0.96 |
Secondary outcomeNumber· Baseline to Week 28
Percentage of Participants Achieving HbA1c <7.0% at Week 28
| Group | Value (Percentage of participants) |
|---|---|
| Exenatide | 32.6 |
| Placebo | 7.0 |
Secondary outcomeLeast squares mean· Baseline to Week 28
Change From Baseline to Week 28 in Daily Insulin Dose
| Group | Value (Units) |
|---|---|
| Exenatide | 1.6 |
| Placebo | 3.5 |
Secondary outcomeNumber· Baseline to Week 28
Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks
| Group | Value (Percentage of participants) |
|---|---|
| Exenatide | 22.2 |
| Placebo | 2.2 |
Secondary outcomeLeast squares mean· Baseline to Week 28
Change in Seated Systolic Blood Pressure From Baseline to Week 28
| Group | Value (millimeter of mercury) |
|---|---|
| Exenatide | -2.5 |
| Placebo | -0.7 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ExenatideExenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin. | 0 / 231 | 11 / 231 | 40 / 231 |
| PlaceboPlacebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin. | 1 / 229 | 11 / 229 | 36 / 229 |
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
Studies2
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2018
9 results
Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study.
Guja et al. 2018Diabetes, obesity & metabolismcited by 55
PMID 29473704PMC6032936DOI 10.1111/dom.13266PUB-29473704
Free to read · publisher termsCC BY-NC9 results
More studies
1 study on this page
PubMed tag: none · 2020
Corrected
Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.
Guja et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 6
PMID 32306296PMC7324446DOI 10.1007/s13300-020-00815-zPUB-32306296
Free to read · publisher termsCC BY-NC
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 130 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria:
* Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)
* Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).
* Has fasting plasma glucose (FPG) concentration \<280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)
* Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:
1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit
Exclusion criteria:
* Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
* History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
* Positive serological test for hepatitis B or hepatitis C
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