Non-Insulin-Dependent Diabetes MellitusPhase 2NCT00156897
Efficacy and Safety of ATL-962 in Obese Diabetics
A Phase 2 study testing ATL-962 and Orlistat in people with Non-Insulin-Dependent Diabetes Mellitus and Obesity, run by Alizyme at 37 sites in 5 countries.
Trial summary
The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Insulin-Dependent Diabetes Mellitus, Obesity
- What is being tested?
- ATL-962 and Orlistat
- How many people
- 600 participants
- Where
- 37 sitesin 5 countries
- Study dates
- Dec 2004to Oct 2005
- 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
- Type II diabetes
- Body mass index 28-45kg/m2
- HbA1c 6%-10%
Who cannot join
- Significant weight loss in the previous 3 months
- Weight gain during the run-in period
- Other serious systemic conditions, except controlled hypertension, mild asthma, and primary hypothyroidism
- History of GI disorders
- Previous surgery for weight loss
Trial locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
United Kingdom14 sites
Aberdeen Royal Infirmary
Aberdeen
Royal United Hospital
Bath
Clinical Research Centre Edgbaston
Birmingham
Walsgrave Hospital
Coventry
Glasgow Royal Infirmary
Glasgow
Clinical Research Centre, Crosby
Liverpool
Liverpool University Hospital
Liverpool
Queen Mary's School of Medicine & Dentistry
London, E1 2AA
Hammersmith Hospital
London
Luton & Dunstable Hospital
Luton
Clinical Research Centre
Manchester
James Cook University Hospital
Middlesbrough
Royal Shrewsbury Hospital
Shrewsbury
Clinical Research Centre
Wigan
Finland7 sites
Lääkärikeskus Minerva
Eura, 27510
Obesity Research Unit
Helsinki, 00100
Suomen Terveystalo
Jyväskylä, 40100
Oy Foodfiles Limited
Kuopio
Oulun Diakonissalaitos
Oulu, 90100
University of Oulu
Oulu
Turku University Hospital
Turku, 20520
Denmark6 sites
Aalborg Sygehus Nord
Aalborg
Aarhus University Hospital
Aarhus, DK-8000
Bispebjerg Hospital
Copenhagen, DK-2400
Gentofte Hospital
Hellerup, DK-2900
Hvidovre Hospital
Hvidovre, DK-2650
Odense University Hospital
Odense
Netherlands5 sites
Allevon
Den Bosch Ziekenhuis
Allevon
DN de Bilt
Zeikenhuisgroep Twente
Hengelo
Nederlandse Obesitas Klinik
Hilversum
Sint Franciscus Gasthuis
Rotterdam
Sweden5 sites
Sahlgrenska University Hospital
Gothenburg
Linkoping University Hospital
Linköping
Karolinsaka University Hospital
Stockholm
Norrlands Universitetssjukhus
Umeå
Samariterhemmets Sjukhus
Uppsala
About this study
Official title: Multicentre Double Blind Placebo Controlled Parallel Group Dose Ranging Study of ATL-962 to Assess Weight Loss, Safety and Tolerability in Obese Patients With Type II Diabetes Being Treated With Metformin, in Comparison With Orlistat
The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients
Read the detailed description
Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.
In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of ATL-962 and orlistat.
- Conditions
- Non-Insulin-Dependent Diabetes Mellitus, Obesity
- Being tested
- ATL-962, Orlistat
- Keywords
- Non-insulin-dependent diabetes mellitus, NIDDM, Type II diabetes, Obesity, Lipase inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATL-962Drug
OrlistatDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute weight loss compared to baseline
Secondary outcomes (6)
Proportion of patients achieving 5% or 10% weight loss
Changes in waist circumference
Changes in lipid profiles
Changes in markers of diabetes
Incidence of gastrointestinal adverse effects
Changes in other safety parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2004
- Study completionOct 2005
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 Non-Insulin-Dependent Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Alizyme
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Kopelman, Principal investigator, Queen Mary's School of Medicine & Dentistry, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156897
- Sponsor's protocol ID
- ATL-962/175/CL
- Status last verified
- Aug 2006
- First submitted
- 8 Sep 2005
- Last updated
- 29 Aug 2006
- Results posted
- No
Publications
Kopelman P, Groot Gde H, Rissanen A, Rossner S, Toubro S, Palmer R, Hallam R, Bryson A, Hickling RI. Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat (Xenical). Obesity (Silver Spring). 2010 Jan;18(1):108-15. doi: 10.1038/oby.2009.155. Epub 2009 May 21.
PubMed 19461584
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Double Blind Placebo Controlled Parallel Group Dose Ranging Study of ATL-962 to Assess Weight Loss, Safety and Tolerability in Obese Patients With Type II Diabetes Being Treated With Metformin, in Comparison With Orlistat
- ClinicalTrials.gov ID
- NCT00156897
- Acronym / sponsor ID
- ATL-962/175/CL
- Conditions
- Non-Insulin-Dependent Diabetes Mellitus, Obesity
- Keywords
- Non-insulin-dependent diabetes mellitus, NIDDM, Type II diabetes, Obesity, Lipase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- AlizymeIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Oct 2005
- First posted
- 12 Sep 2005 (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.
The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients
Detailed description
Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.
In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of ATL-962 and orlistat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type II diabetes
- Body mass index 28-45kg/m2
- HbA1c 6%-10%
Key exclusion criteria (5 listed)
- Significant weight loss in the previous 3 months
- Weight gain during the run-in period
- Other serious systemic conditions, except controlled hypertension, mild asthma, and primary hypothyroidism
- History of GI disorders
- Previous surgery for weight loss
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 |
|---|---|---|
| ATL-962 | Drug | – |
| Orlistat | Drug | – |
Primary outcome
Absolute weight loss compared to baseline
6 secondary outcomes
Proportion of patients achieving 5% or 10% weight loss
Changes in waist circumference
Changes in lipid profiles
Changes in markers of diabetes
Incidence of gastrointestinal adverse effects
Changes in other safety parameters
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 29 Aug 2006.
- Derived from this study: PubMed 19461584Kopelman P, Groot Gde H, Rissanen A, Rossner S, Toubro S, Palmer R, Hallam R, Bryson A, Hickling RI. Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat (Xenical). Obesity (Silver Spring). 2010 Jan;18(1):108-15. doi: 10.1038/oby.2009.155. Epub 2009 May 21.
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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.
Peter Kopelman principal investigator
Queen Mary's School of Medicine & Dentistry, London, UK
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATL-962 and Orlistat in people with Non-Insulin-Dependent Diabetes Mellitus and Obesity, run by Alizyme at 37 sites in 5 countries.
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 3 inclusion and 5 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 29 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United Kingdom, Finland, Denmark, Netherlands, Sweden. 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. 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?
Absolute weight loss compared to baseline. 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 NCT00156897, 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 29 Aug 2006.