Type 2 Diabetes MellitusPhase 4GLYCEMIANCT01238978
Phase 4 Study in the Elderly Patients With T2DM
A Phase 4 study testing Vildagliptin in people with Type 2 Diabetes Mellitus and Elderly, run by Novartis at 15 sites in France.
Trial summary
The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Elderly
- What is being tested?
- Vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 15 sitesFrance
- Study dates
- Oct 2010to Dec 2011
- Phase
- Phase 4
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Type 2 Diabetes Mellitus (DM) patients aged 65 to 80 years, willing to perform SMBG in case of symptomatic hypoglycemia.
- HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months.
Who cannot join
- Age > 80 yrs
- BMI < 22 and ≥ 45 kg/m2
- Secondary T2 DM
- Hepatic failure, moderate/severe renal failure (Cl < 50 ml/min) and CHF III \& IV
- ASAT / ALAT > 3 ULN, creatinine clearance < 50 ml/min Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Novartis Investigative Site
Armentières, 59208
Novartis Investigative Site
Brest, 29200
Novartis Investigative Site
Caen, 14000
Novartis Investigative Site
Creil, 60100
Novartis Investigative Site #2
Paris, 75012
Novartis Investigative Site
Paris, 75020
Novartis Investigative Site
Pau, 64000
Novartis Investigative Site
Saint-Jean-de-la-Ruelle, 45140
Novartis Investigative Site
Strasbourg, 67000
Novartis Investigative Site
Strasbourg
Novartis Investigative Site
Toulouse, 31200
Novartis Investigative Site
Tours, 37000
Novartis Investigative Site
Vénissieux, 69200
Novartis Investigative Site #2
Vénissieux
Novartis Investigative Site
Versailles, 78000
About this study
Official title: A Multicenter, Prospective, Randomized, Open-label, Parallel Group Study to Investigate the Clinical Benefit on Hypoglycemia Frequency of 24 Weeks Treatment With Galvus Versus Usual Care (Any OAD of Another Class Added to Metformin Within SmPc) in Older Patients With Type 2 Diabetes Insufficiently Controlled by Metformin Monotherapy.
The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin
- Conditions
- Type 2 Diabetes Mellitus, Elderly
- Being tested
- Vildagliptin, "Usual Care"
- Keywords
- Diabetes mellitus, vildagliptin, hypoglycemia, elderly
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
"Usual Care"Drug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Not described Receives: Drug: Vildagliptin |
| other Oral Antidiabetic Drug in a different therapeutic class | Active comparator | Not described Receives: Drug: "Usual Care" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients in each of the two treatment groups presenting no hypoglycemia (confirmed events with SMBG and severe episodes) after 24 wk of randomized therapy added to their ongoing metformin background therapy.
Measured: 24 weeks
Secondary outcomes (3)
Percent of patients reaching their therapeutic goal
Measured: 24 weeks
Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal
Measured: 24 weeks
Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
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 Type 2 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238978
- Sponsor's protocol ID
- CLAF237AFR03
- Acronym
- GLYCEMIA
- Status last verified
- Feb 2017
- First submitted
- 9 Nov 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Penfornis A, Bourdel-Marchasson I, Quere S, Dejager S. Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. Diabetes Metab. 2012 Dec;38(6):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18.
PubMed 22996038
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Open-label, Parallel Group Study to Investigate the Clinical Benefit on Hypoglycemia Frequency of 24 Weeks Treatment With Galvus Versus Usual Care (Any OAD of Another Class Added to Metformin Within SmPc) in Older Patients With Type 2 Diabetes Insufficiently Controlled by Metformin Monotherapy.
- ClinicalTrials.gov ID
- NCT01238978
- Acronym / sponsor ID
- GLYCEMIA / CLAF237AFR03
- Conditions
- Type 2 Diabetes Mellitus, Elderly
- Keywords
- Diabetes mellitus, vildagliptin, hypoglycemia, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Nov 2010 (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 study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: Vildagliptin |
| other Oral Antidiabetic Drug in a different therapeutic class | Active comparator | Drug: "Usual Care" |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes Mellitus (DM) patients aged 65 to 80 years, willing to perform SMBG in case of symptomatic hypoglycemia.
- HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months.
Key exclusion criteria (5 listed)
- Age > 80 yrs
- BMI < 22 and ≥ 45 kg/m2
- Secondary T2 DM
- Hepatic failure, moderate/severe renal failure (Cl < 50 ml/min) and CHF III \& IV
- ASAT / ALAT > 3 ULN, creatinine clearance < 50 ml/min Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Vildagliptin | Drug | Vildagliptin |
| "Usual Care" | Drug | other Oral Antidiabetic Drug in a different therapeutic class |
Primary outcome
Percent of patients in each of the two treatment groups presenting no hypoglycemia (confirmed events with SMBG and severe episodes) after 24 wk of randomized therapy added to their ongoing metformin background therapy.
Time frame: 24 weeks
3 secondary outcomes
Percent of patients reaching their therapeutic goal
Time frame: 24 weeks
Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal
Time frame: 24 weeks
Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks.
Time frame: 24 weeks
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 23 Feb 2017.
- Results publication: PubMed 22996038Penfornis A, Bourdel-Marchasson I, Quere S, Dejager S. Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. Diabetes Metab. 2012 Dec;38(6):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vildagliptin in people with Type 2 Diabetes Mellitus and Elderly, run by Novartis at 15 sites in France.
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 2 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
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?
Percent of patients in each of the two treatment groups presenting no hypoglycemia (confirmed events with SMBG and severe episodes) after 24 wk of randomized therapy added to their ongoing metformin background therapy. (time frame: 24 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 NCT01238978, 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 23 Feb 2017.