SchizophreniaPhase 4NCT00190749

Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

A Phase 4 study testing olanzapine and risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: olanzapine and risperidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteUnited States
Study dates: Oct 2003to Jun 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

18-65 years old
Diagnosed with Schizophrenia or Schizoaffective disorder
Ability to visit the doctor's office for scheduled visits

Who cannot join

Women who are pregnant or breastfeeding
Have a body mass index (BMI) greater than 40
Have diabetes, heart disease or any other unstable illness
Have known positive human immunodeficiency virus (HIV)
Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics

Trial locations and contacts

1 site in 1 country.

United States1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, 92161

Other trials in United States

About this study

Official title: Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: olanzapine, risperidone
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

olanzapineDrug
Also called LY170053, Zyprexa
5-20 mg, oral, capsules, daily, 12 weeks.
risperidoneDrug
2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

Study groups in NCT00190749
Study group	Role	What they receive
Olanzapine	Experimental	Not described Receives: Drug: olanzapine
Risperidone	Active comparator	Not described Receives: Drug: risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)]
Measured: baseline and 12 weeks

Secondary outcomes (29)

Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.
Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores
Measured: 12 weeks
Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area
Measured: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area
Measured: 12 weeks
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores
Measured: 12 weeks
Change From Baseline to 12 Week Endpoint in Body Mass Index
Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Weight
Weight change from baseline to last visit (last observation carried forward)
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Waist Circumference
Waist circumference change from baseline to last observation carried forward.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Visceral Fat Area
Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area
Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area
Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores
A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores
The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores
Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always).
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol
Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)
Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)
Fasting lipid parameters including HDL change from baseline to last observation carried forward.
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides
Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline
Measured: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein.
Measured: baseline and 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2003Jun 2008

First posted19 Sep 2005 (estimated)
Study startOct 2003
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00190749
Sponsor's protocol ID: 5296
Other IDs: F1D-MC-S014
Status last verified: Apr 2010
First submitted: 12 Sep 2005
Last updated: 4 May 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.
PubMed 20840778

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone
ClinicalTrials.gov ID: NCT00190749
Acronym / sponsor ID: 5296
Conditions: Schizophrenia, Schizoaffective Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2003
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 23 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Olanzapine	Experimental	Drug: olanzapine
Risperidone	Active comparator	Drug: risperidone

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18-65 years old
Diagnosed with Schizophrenia or Schizoaffective disorder
Ability to visit the doctor's office for scheduled visits

Key exclusion criteria (5 listed)

Women who are pregnant or breastfeeding
Have a body mass index (BMI) greater than 40
Have diabetes, heart disease or any other unstable illness
Have known positive human immunodeficiency virus (HIV)
Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics

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
olanzapineAlso: LY170053, Zyprexa5-20 mg, oral, capsules, daily, 12 weeks.	Drug	Olanzapine
risperidone2-6 mg, oral, capsules, twice daily (BID), 12 weeks.	Drug	Risperidone

Primary outcome

Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
Time frame: baseline and 12 weeks
Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)]

29 secondary outcomes

Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.
Time frame: 12 weeks
Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.
Time frame: 12 weeks
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.
Time frame: 12 weeks
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Time frame: 12 weeks
Change From Baseline to 12 Week Endpoint in Body Mass Index
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Weight
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Waist Circumference
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Visceral Fat Area
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides
Time frame: baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Time frame: baseline and 12 weeks.

Results and safety

Results posted to the registry on 23 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olanzapine	68	42
Risperidone	62	31

Primary outcome: Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate

Time frame: baseline and 12 weeks. Mean (Standard Deviation). Unit: Mffm/I

Measure	Olanzapine n = 41	Risperidone n = 33
Baseline	0.1664 (0.1120)	0.1937 (0.1286)
Change to Last Observation	-0.0149 (0.0786)	-0.0327 (0.0829)

Olanzapine: p = 0.226, t-test, 2 sided
Risperidone: p = 0.030, t-test, 2 sided
Olanzapine vs Risperidone: p = 0.204, ANCOVA

Population analysed: N=number of patients with a baseline and post-baseline result within each treatment group for Mffm/I and weight.

29 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olanzapine	2 of 68 (2.9%)	42 of 68 (61.8%)	Not reported
Risperidone	5 of 62 (8.1%)	43 of 62 (69.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20840778Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Schizophrenia

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing olanzapine and risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Eli Lilly and Company at 1 site 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 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 4 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate (time frame: baseline and 12 weeks). 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 NCT00190749, 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 4 May 2010.