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Type 2 Diabetes MellitusPhase 4BENEFITNCT01649466

Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.

A Phase 4 study testing LAF237 and Protaphane in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 53 sites in Germany.

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 is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
LAF237 and Protaphane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
53 sitesGermany
Study dates
Aug 2012to Oct 2013
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of type 2 diabetes mellitus.
  • Contraindicated or intolerant to take metformin.
  • HbA1c of ≥ 7.0% and ≤ 8.5%
  • Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled
  • Other protocol-defined inclusion/exclusion criteria may apply

Who cannot join

  • Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.
  • Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month
  • Patients taking sulfonylurea for longer than 5 years
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
  • pregnancy
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

Germany53 sites

  • Novartis Investigative Site

    Anderbeck, 38836

  • Novartis Investigative Site

    Augsburg, 86150

  • Novartis Investigative Site

    Bad Kreuznach, 55545

  • Novartis Investigative Site

    Bad Oeynhausen, 32549

  • Novartis Investigative Site

    Balingen, 72336

  • Novartis Investigative Site

    Berlin, 10115

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Berlin, 10627

  • Novartis Investigative Site

    Berlin, 12347

  • Novartis Investigative Site

    Berlin, 13189

  • Novartis Investigative Site

    Berlin, 13597

  • Novartis Investigative Site

    Cologne, 51069

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Dresden, 01099

  • Novartis Investigative Site

    Dresden, 01309

  • Novartis Investigative Site

    Einbeck, 37574

  • Novartis Investigative Site

    Eisleben Lutherstadt, 06295

  • Novartis Investigative Site

    Elsterwerda, 04910

  • Novartis Investigative Site

    Essen, 45219

  • Novartis Investigative Site

    Essen, 45276

  • Novartis Investigative Site

    Fulda, 36037

  • Novartis Investigative Site

    Gelnhausen, 63571

  • Novartis Investigative Site

    Graben-Neudorf, 76676

  • Novartis Investigative Site

    Grossheirath-Rossach, 96269

  • Novartis Investigative Site

    Herne, 44653

  • Novartis Investigative Site

    Hildesheim, 31139

  • Novartis Investigative Site

    Kassel, 34125

  • Novartis Investigative Site

    Kassel, 34127

  • Novartis Investigative Site

    Kleve, 47533

  • Novartis Investigative Site

    Lienen, 49536

  • Novartis Investigative Site

    Löhne, 32584

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mainz, 55116

  • Novartis Investigative Site

    Mayen, 56727

  • Novartis Investigative Site

    Mülheim, 45468

  • Novartis Investigative Site

    München, 80339

  • Novartis Investigative Site

    München, 81373

  • Novartis Investigative Site

    Oschatz, 04758

  • Novartis Investigative Site

    Potsdam, 14469

  • Novartis Investigative Site

    Reinfeld, 23858

  • Novartis Investigative Site

    Saarlouis, 66740

  • Novartis Investigative Site

    Saint Ingbert - Oberwuerzbach, 66386

  • Novartis Investigative Site

    Schliemannstadt Neubukow, 18233

  • Novartis Investigative Site

    Straubing, 94315

  • Novartis Investigative Site

    Stuttgart, 70191

  • Novartis Investigative Site

    Villingen-Schwenningen, 78054

  • Novartis Investigative Site

    Wallerfing, 94574

  • Novartis Investigative Site

    Wangen, 88239

  • Novartis Investigative Site

    Wedemark, 30900

  • Novartis Investigative Site

    Weiskirchen, 66709

  • Novartis Investigative Site

    Wetzlar-Naunheim, 35584

  • Novartis Investigative Site

    Würzburg, 97072

  • Novartis Investigative Site

    Wurzen, 04808

Other trials in Germany

About this study

Official title: A Randomized Open-label Study to Compare Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Patients With Type 2 Diabetes Mellitus That do Not Reach Adequate Glycemic Control on Their Current Sulfonylurea Monotherapy.

This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.

Being tested
LAF237, Protaphane
Keywords
Type 2 diabetes mellitus, diabetes
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.

  • LAF237Drug

    Vildagliptin will be used as commercially available tablets of 50mg.

  • ProtaphaneDrug

    Protaphane will be used as commercially available injection pens

Study groups in NCT01649466
Study groupRoleWhat they receive
VildagliptinExperimentalPatients randomized to the vildagliptin group will receive 50mg vildagliptin once daily add-on to their current glimepiride monotherapy for 24 weeks. No dose titrations are permitted during the study.
Receives: Drug: LAF237
ProtaphaneActive comparatorPatients randomized to the Protaphane group will receive a individualized dose of Protaphane once daily as bedtime dose. The Protaphane dose will be titrated within the first 4 weeks to reach fasting plasma glucose values below 100 mg/dl.
Receives: Drug: Protaphane

What is being measured

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

  1. Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain

    Primary endpoint is proportion of patients reaching the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) and weight gain.

    Measured: 24 weeks

  2. Rate of confirmed hypoglycemic events

    Co-primary endpoint is to evaluate the rate of confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) in type 2 diabetes patients treated with vildagliptin versus NPH insulin add-on to glimepiride.

    Measured: 24 weeks

Secondary outcomes (6)

  1. Incidence of severe hypoglycemic events

    To evaluate the incidence of severe hypoglycemic events (suspected grade 2 and confirmed grade 2 events) in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.

    Measured: 24 weeks

  2. Incidence of symptomatic hypoglycemic events

    To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.

    Measured: 24 weeks

  3. Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event

    To evaluate the percentage of patients treated with vildagliptin versus NPH insulin add-on to glimepiride who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events.

    Measured: 24 weeks

  4. Change from baseline in body weight at 24 weeks

    To evaluate body weight changes between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.

    Measured: Baseline, 24 week

  5. Change from baseline in HbA1c at 24 weeks

    To evaluate changes in HbA1c between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.

    Measured: Baseline, 24 week

  6. Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week

    The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication.

    Measured: Baseline, 24 week

Timeline

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

  1. First posted25 Jul 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01649466
Sponsor's protocol ID
CLAF237ADE08
Other IDs
2012-001143-46
Acronym
BENEFIT
Status last verified
Nov 2016
First submitted
20 Jul 2012
Last updated
17 Nov 2016
Results posted
No

Publications

  • Forst T, Koch C, Dworak M. Vildagliptin versus insulin in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea: results from a randomized, 24 week study. Curr Med Res Opin. 2015 Jun;31(6):1079-84. doi: 10.1185/03007995.2015.1039936. Epub 2015 May 20.

    PubMed 25867771

  • Zuckermann A, Wang SS, Ross H, Frigerio M, Eisen HJ, Bara C, Hoefer D, Cotrufo M, Dong G, Junge G, Keogh AM. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial. J Transplant. 2011;2011:535983. doi: 10.1155/2011/535983. Epub 2011 Sep 13.

    PubMed 22295178

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing LAF237 and Protaphane in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 53 sites in Germany.

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 5 inclusion and 6 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Germany. 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?

Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT01649466, which also lists 2 linked publications.

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 17 Nov 2016.

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