Diabetes Mellitus, Non-Insulin-DependentPhase 2NCT00044694
Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing AC2993 2.5 mcg in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 33 sites in United States.
Trial summary
This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- AC2993 2.5 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 33 sitesUnited States
- Study dates
- Aug 2002to May 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 2 diabetes
- Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
- BMI 27-45 kg/m^2
- HbA1c between 7.0 % and 8.0 %
Who cannot join
- Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
- Patients previously treated with AC2993
- Patients presently treated with insulin
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Endocrinology Clinic of O.C.
Anaheim, California, 92801
Anshutz Outpatient Pavilion
Aurora, Colorado, 80010
Pioneer Medical Group
Bellflower, California, 90706
Millenium Research
Benbrook, Texas, 76126
Innovative Clinical Trials
Birmingham, Alabama, 35209
Healthsouth Clinical Research
Birmingham, Alabama, 35243
Clinical Research Group of North Georgia
Blairsville, Georgia, 30512
Radiant Research-Boise
Boise, Idaho, 83704
Carolina Advanced Research
Cary, North Carolina, 27511
Cedar-Crosse Research Center
Chicago, Illinois, 60607
International Clinical Research Network
Chula Vista, California, 91910
Diagnostic Clinic
Clearwater, Florida, 33760
Melvin Kramer, MD
Concord, Massachusetts, 01742
Northshore Medical Research, LLC
Covington, Louisiana, 70433
Healthsouth Clinical Research
DeSoto, Texas, 75115
Radiant Research-Edina
Edina, Minnesota, 55435
Bautista Research and Medical Clinic
Fresno, California, 93721
Radiant Research-Gainsville
Gainsville, Florida, 32605
Mississippi Medical Research, LLC
Gulfport, Mississippi, 39501
East-West Medical Research Institute
Honolulu, Hawaii, 96813
Radiant Research-Honolulu
Honolulu, Hawaii, 96814
Baylor College of Medicine/Clinical Studies Unit
Houston, Texas, 77030
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Whittier Institute for Diabetes
La Jolla, California, 92037
Innovative Health Research
Las Vegas, Nevada, 89119
Richard Cherlin, M.D.
Los Gatos, California, 95032
Fallen Timbers Internal Medicine, LLC
Maumee, Ohio, 43537
Diabetes Center of the Southwest
Midland, Texas, 79705
Dr. Martinez Medical Clinic
Moreno Valley, California, 92553
Radiant Research-Pinellas Park
Pinellas Park, Florida, 33781
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, 84108
Medical Research Institute
Slidell, Louisiana, 70458
About this study
Official title: A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus
This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- Placebo 0.01 mL, Placebo 0.02 mL, Placebo 0.03 mL, Placebo 0.04 mL, AC2993 2.5 mcg
- Keywords
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo 0.01 mLDrug
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
Placebo 0.02 mLDrug
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
Placebo 0.03 mLDrug
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
Placebo 0.04 mLDrug
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
AC2993 2.5 mcgDrug
Also called synthetic exendin-4
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
AC2993 5.0 mcgDrug
Also called synthetic exendin-4
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
AC2993 7.5 mcgDrug
Also called synthetic exendin-4
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
AC2993 10.0 mcgDrug
Also called synthetic exendin-4
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo 0.01 mL | Placebo comparator | 2 week placebo lead-in followed by Placebo 0.01 mL Receives: Drug: Placebo 0.01 mL |
| Placebo 0.02 mL | Placebo comparator | 2 week placebo lead-in followed by Placebo 0.02 mL Receives: Drug: Placebo 0.02 mL |
| Placebo 0.03 mL | Placebo comparator | 2 week placebo lead-in followed by Placebo 0.03 mL Receives: Drug: Placebo 0.03 mL |
| Placebo 0.04 mL | Placebo comparator | 2 week placebo lead-in followed by Placebo 0.04 mL Receives: Drug: Placebo 0.04 mL |
| AC2993 2.5 mcg | Experimental | 2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL Receives: Drug: AC2993 2.5 mcg |
| AC2993 5.0 mcg | Experimental | 2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL Receives: Drug: AC2993 5.0 mcg |
| AC2993 7.5 mcg | Experimental | 2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL Receives: Drug: AC2993 7.5 mcg |
| AC2993 10.0 mcg | Experimental | 2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL Receives: Drug: AC2993 10.0 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
Measured: Baseline (Day 1) to Day 28
Secondary outcomes (3)
Change in HbA1c from Baseline to Day 14
Change in HbA1c from Baseline (Day 1) to Day 14
Measured: Baseline, Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28
Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)
Measured: Baseline, Day 14, Day28
Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28
Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Measured: Baseline, Day 14, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2002 (estimated)
- Study startAug 2002
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044694
- Sponsor's protocol ID
- 2993-116
- Status last verified
- Jan 2015
- First submitted
- 3 Sep 2002
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26. doi: 10.1089/dia.2006.0024.
PubMed 17705687
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00044694
- Acronym / sponsor ID
- 2993-116
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 5 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo 0.01 mL | Placebo comparator | Drug: Placebo 0.01 mL2 week placebo lead-in followed by Placebo 0.01 mL |
| Placebo 0.02 mL | Placebo comparator | Drug: Placebo 0.02 mL2 week placebo lead-in followed by Placebo 0.02 mL |
| Placebo 0.03 mL | Placebo comparator | Drug: Placebo 0.03 mL2 week placebo lead-in followed by Placebo 0.03 mL |
| Placebo 0.04 mL | Placebo comparator | Drug: Placebo 0.04 mL2 week placebo lead-in followed by Placebo 0.04 mL |
| AC2993 2.5 mcg | Experimental | Drug: AC2993 2.5 mcg2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL |
| AC2993 5.0 mcg | Experimental | Drug: AC2993 5.0 mcg2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL |
| AC2993 7.5 mcg | Experimental | Drug: AC2993 7.5 mcg2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL |
| AC2993 10.0 mcg | Experimental | Drug: AC2993 10.0 mcg2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with type 2 diabetes
- Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
- BMI 27-45 kg/m^2
- HbA1c between 7.0 % and 8.0 %
Key exclusion criteria (3 listed)
- Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
- Patients previously treated with AC2993
- Patients presently treated with insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo 0.01 mL2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily | Drug | Placebo 0.01 mL |
| Placebo 0.02 mL2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily | Drug | Placebo 0.02 mL |
| Placebo 0.03 mL2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily | Drug | Placebo 0.03 mL |
| Placebo 0.04 mL2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily | Drug | Placebo 0.04 mL |
| AC2993 2.5 mcgAlso: synthetic exendin-42-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily | Drug | AC2993 2.5 mcg |
| AC2993 5.0 mcgAlso: synthetic exendin-42-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily | Drug | AC2993 5.0 mcg |
| AC2993 7.5 mcgAlso: synthetic exendin-42-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily | Drug | AC2993 7.5 mcg |
| AC2993 10.0 mcgAlso: synthetic exendin-42-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily | Drug | AC2993 10.0 mcg |
Primary outcome
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
Time frame: Baseline (Day 1) to Day 28
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
3 secondary outcomes
Change in HbA1c from Baseline to Day 14
Time frame: Baseline, Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28
Time frame: Baseline, Day 14, Day28
Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28
Time frame: Baseline, Day 14, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Derived from this study: PubMed 17705687Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26. doi: 10.1089/dia.2006.0024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AC2993 2.5 mcg in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 (time frame: Baseline (Day 1) to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.