Diabetes Mellitus, Type 2NCT01332370
Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone
An observational study of Diabetes Mellitus, Type 2, run by GlaxoSmithKline.
Trial summary
This retrospective database study analyzed resource utilization and costs associated with sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a large US healthcare plan. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rosiglitazone + Metformin and Sitagliptin + Metformin
- How many people
- 5,391 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Dec 2010
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults continuously enrolled in a large US health insurance plan with a diagnosis of diabetes who are currently receiving Metformin
Who may be able to join
- Continuously enrolled in the health insurance plan to ensure complete claims coverage
- At least 1 claim with a diagnosis of diabetes (ICD-9 250.xx)
- Aged 18 years or older at the index date
- At least 6 months of baseline period prior to the index date
- At least 1 claim for MET during the baseline period
- At least 180 days of continuous therapy with RSG+MET or STG+MET after the index date
Who cannot join
- At least 1 claim for insulin or sulfonylurea in the baseline period
- At least 1 claim with a diagnosis of congestive heart failure in the baseline period
About this study
This retrospective database study analyzed resource utilization and costs associated with sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a large US healthcare plan.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rosiglitazone + Metformin, Sitagliptin + Metformin
- Keywords
- Retrospective, Type 2 Diabetes, Cost Analysis, Rosiglitazone, Sitagliptin
- 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.
Rosiglitazone + MetforminDrug
Also called Avandia(TM)
At least 180 days of continuous therapy with RSG+MET after the first Rx for RSG
Sitagliptin + MetforminDrug
Also called Januvia(R)
At least 180 days of continuous therapy with STG+MET after the first Rx for STG
| Study group | Role | What they receive |
|---|---|---|
| Adults with Type 2 Diabetes | Subjects with a diagnosis (ICD-9 code) of diabetes Receives: Drug: Rosiglitazone + Metformin; Drug: Sitagliptin + Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
medical resource utilization
Direct healthcare and indirect sick leave costs
Measured: at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,391 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332370
- Sponsor's protocol ID
- 112611
- Status last verified
- Jun 2011
- First submitted
- 7 Apr 2011
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone
- ClinicalTrials.gov ID
- NCT01332370
- Acronym / sponsor ID
- 112611
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Retrospective, Type 2 Diabetes, Cost Analysis, Rosiglitazone, Sitagliptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,391 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Apr 2011 (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 retrospective database study analyzed resource utilization and costs associated with sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a large US healthcare plan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Type 2 Diabetes | – | Drug: Rosiglitazone + Metformin, Drug: Sitagliptin + MetforminSubjects with a diagnosis (ICD-9 code) of diabetes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults continuously enrolled in a large US health insurance plan with a diagnosis of diabetes who are currently receiving Metformin
Key inclusion criteria (6 listed)
- Continuously enrolled in the health insurance plan to ensure complete claims coverage
- At least 1 claim with a diagnosis of diabetes (ICD-9 250.xx)
- Aged 18 years or older at the index date
- At least 6 months of baseline period prior to the index date
- At least 1 claim for MET during the baseline period
Key exclusion criteria (2 listed)
- At least 1 claim for insulin or sulfonylurea in the baseline period
- At least 1 claim with a diagnosis of congestive heart failure in the baseline period
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 |
|---|---|---|
| Rosiglitazone + MetforminAlso: Avandia(TM)At least 180 days of continuous therapy with RSG+MET after the first Rx for RSG | Drug | Adults with Type 2 Diabetes |
| Sitagliptin + MetforminAlso: Januvia(R)At least 180 days of continuous therapy with STG+MET after the first Rx for STG | Drug | Adults with Type 2 Diabetes |
Primary outcome
medical resource utilization
Time frame: at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy.
Direct healthcare and indirect sick leave costs
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 2 Jun 2017.
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by GlaxoSmithKline.
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 6 inclusion and 2 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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
medical resource utilization (time frame: at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2017.