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Type 2 Diabetes MellitusPhase 2NCT00455598

Placebo Controlled, Dose Escalation Study in Subjects With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea

A Phase 2 study testing ISIS 113715 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 39 sites in 3 countries.

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

The purpose of this study is to provide an initial assessment of the safety, tolerability and efficacy of ISIS 113715 in combination with sulfonylurea in type 2 diabetes subjects. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
ISIS 113715
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
39 sitesin 3 countries
Study dates
Feb 2007to May 2009
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes mellitus of less than or equal to eight years in duration, diagnosed according to American Diabetes Association criteria
  • Fasting serum glucose from 150 to 270 mg/dL at screening visit
  • HbA1c from 7.5 to 11.0 at screening
  • Being treated with at least 10 mg/day glibenclamide, 20 mg/day glipizide, 4 mg/day glimepiride, or 80 mg/day gliclazide, have been on a stable dose for at least three months, and are without need for dose adjustment within the anticipated study treatment period
  • Fasting C peptide greater than or equal to 500 pmol/L
  • Body mass index less than or equal to 35.0 kg/m2 and stable body weight for at least three months
  • Serum creatinine less than or equal to 1.2 mg/dL for females or less than or equal to 1.5 mg/dL for males

Who cannot join

  • Prior treatment with ISIS 113715
  • Undergoing or have undergone treatment with any non marketed, therapeutic agent or device within 90 days prior to screening
  • Subjects who have had more than three episodes of severe hypoglycemia within six months (i.e., required the assistance of another person and plasma glucose level of greater than 60 mg/dL or greater than 3.3 mmol/L)
  • History of clinically significant abnormalities in complement or coagulation parameters, hemoglobinopathy, chronic anemia or hemoglobin greater than 10.5 mg/dL for females and greater than 11.5 mg/dL for males
  • Clinically significant complications of diabetes (e.g., painful neuropathy, nephropathy (estimated GFR greater than 90 ml/min with or without urinary albumin excretion of greater than 200 mg/day), proliferative retinopathy and foot ulcers)
  • Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT greater than 1.5x ULN (no repeat draws permitted)
Show all 14Show fewer
  • A positive hepatitis B surface antigen, hepatitis C antibody, or HIV test Treatment with statins at a stable dose for less than three months prior to screening. Simvastatin dosages of up to 40 mg/day are allowed. Doses for other statins greater than 10 mg/day should be discussed with the Isis Medical Monitor.
  • Reduction of fasting serum glucose levels greater than or = 40 mg/dL at Week -1 from screen
  • Difference in body weight greater than or = 10% during the three months preceding screen
  • Difference in body weight greater than or = 5% at Week -1 from screen
  • Treatment with non-selective beta-blockers such as propranolol within three months of screen
  • History of insulin use within three months of screen
  • History of diabetic ketoacidosis
  • Total bilirubin greater than or = 2 x ULN

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

Romania16 sites

  • Arad Emergency Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases

    Arad, 310158

  • Cardiology Private PRactice "Dr. Calin Pop"

    Baia Mare, 430123

  • Private Practice SC "Diabol" SRL

    Brasov, 500365

  • Private Practice Nicodiab SRL

    Bucharest, 010507

  • Medical Centre of Diagnosis, Outpatient Treatment and Preventive Medicine, Department of Diabetes, Nutrition and Metabolic Diseases

    Bucharest, 011794

  • "Prof. Dr. N.C. Paulescu" National Institute of Diabetes, Nutrition and Metabolic Diseases, 1st Clinical Department of Diabetes, Nutrition and Metabolic Diseases

    Bucharest, 020475

  • "Nicolae Malaxa" Clinical Hospital, Department of Diabetes, Nutrition and Metabolic Diseases

    Bucharest, 022441

  • Cluj Emergency Clinical County Hospital

    Cluj-Napoca, 400006

  • Deva County Hospital, Department of Internal Medicine

    Deva, 330084

  • Private Practice "Morosanu V. Magdalena"

    Galati, 800371

  • Oradea Clinical County Hospital, Department of Diabetes, Nutrition and Metabolic Diseases

    Oradea, 410032

  • S.C. Diabmed Dr. Popescu Alexandrina SRL

    Ploieşti, 100163

  • Satu Mare County Hospital, Department of Diabetology and Nutrition Diseases

    Satu Mare, 440055

  • Sibiu Clinical County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases

    Sibiu, 550245

  • "Sf. Ioan cel Nou" Suceava Emergencency County Hospital, Clinic of Diabetes, Nutrition and Metabolic Diseases

    Suceava, 720284

  • Private Practice "Dr. Gagiu Remus"

    Targoviste, 130083

Other trials in Romania

Russia16 sites

  • State Institution of Healthcare "Kemerovo Regional Clinical Hospital"

    Kemerovo, 650066

  • State Institution "Endocrinology Scientific Center of the RAMS",

    Moscow, 115478

  • Medical Institution Public Corporation Polyclinic "Gazprom"

    Moscow, 117420

  • Close Corporation "MEDSI"

    Moscow, 123056

  • State Educational Institution of Continuing Professional Education "Russian Medical Academy of Postgraduate Education of the Federal Agency of Health and Social Development", Chair of Endocrinology and Diabetology, Non-State Institution of Public Hea

    Moscow, 125315

  • State Institution "Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

    Moscow, 129110

  • Limited Liability Company "Clinic of New Medical Technologies"

    Moscow, 140091

  • Regional State Institution of Healthcare "Novosibirsk State Regional Clinical Hospital"

    Novosibirsk, 630087

  • State Institution Scientific Research Institute of Therapy of the Siberian Department of the Russian Academy of Medical Sciences

    Novosibirsk, 630089

  • Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Federal Agency on High Technology Medical Care

    Saint Petersburg, 194156

  • State Educational Institution of Higher Professional Education "Medical-Military Academy named after S.M. Kirov, Clinic of Therapy of Postgraduate Education named after N.S. Molchanov

    Saint Petersburg, 198013

  • Limited Liability Company "Center "Diabetes"

    Samara, 443067

  • Public Medical Institution "City Outpatient Clinic # 20" of Saratov Administration Healthcare

    Saratov, 410018

  • State Educational Institution of High Professional Education "Smolensk State Medical Academy of Federal Agency of Healthcare and Social Development

    Smolensk, 214018

  • State Educational Institution of High Professional Education <Siberian State University of Federal Agency of Healthcare and Social Development

    Tomsk, 634034

  • Municipal Institution of Healthcare Clinical Ambulance Hospital named after N. V. Soloviev

    Yaroslavl, 150003

Other trials in Russia

Poland7 sites

  • Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczny Ośrodek Internistyczno

    Bialystok, 15-435

  • Akademickie Centrum Kliniczne- Szpital Akademii Medycznej w Gdańsku

    Gdansk, 80-952

  • Poradnia Neurologiczna i Poradnia

    Poznan, 61-289

  • Niepubliczny Zakład Opieki

    Radom, 26-610

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Szczecin, 70-361

  • ll Oddzial Chorob Wewnetrznych

    Tychy, 43-100

  • Samodzielny Zespół Publicznych Zakladów Opieki Zdrowotnej

    Wołomin, 05-200

Other trials in Poland

About this study

Official title: A Phase 2, Multi Center, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, PK, & Activity of ISIS 113715 Administered Weekly in Subjects With Type 2 DM Treated w/ Sulfonylurea

The purpose of this study is to provide an initial assessment of the safety, tolerability and efficacy of ISIS 113715 in combination with sulfonylurea in type 2 diabetes subjects.

Read the detailed description

Diabetes is a significant and growing world-wide medical burden. Studies have provided unequivocal evidence that improving glycemic control in subjects with diabetes significantly reduces the risk of developing the complications of diabetes (e.g., retinopathy, nephropathy, and neuropathy). Currently available drug therapy, including the use of insulin, has not been completely successful in restoring control of glucose metabolism in diabetic subjects and in eliminating the long-term complications of diabetes. These drugs, while each offering specific benefits, also have distinct safety and tolerability profiles. Thus, there remains a need for agents with novel mechanism(s) of action.

ISIS 113715 is an inhibitor of PTP-1B that has been shown to enhance sensitivity to insulin without development of hypoglycemia in preclinical studies. Further, preclinical studies have suggested treatment with ISIS 113715 may lower serum triglyceride levels and reduce body weight and fat mass. Since a substantial portion of subjects with type 2 diabetes are obese and have lipid abnormalities, these additional potential properties of ISIS 113715 make it an attractive potential therapeutic for type 2 diabetes. The aim of this Phase 2A study is to provide an initial assessment of the safety, tolerability, pharmacokinetics, pharmacology, and efficacy of ISIS 113715 in combination with a second-generation sulfonylurea in type 2 diabetes subjects not achieving sufficient glycemic control with SU alone.

Being tested
ISIS 113715
Keywords
Diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

  • ISIS 113715Drug

    doses of 100 and 200 mg per week

Study groups in NCT00455598
Study groupRoleWhat they receive
APlacebo comparatorSulfonylurea + 100 mg/week ISIS 113715 or placebo
Receives: Drug: ISIS 113715
BPlacebo comparatorSulfonylurea + 200 mg/week ISIS 113715 or placebo
Receives: Drug: ISIS 113715

What is being measured

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

  1. Change and % change from baseline HbA1c

    Measured: 13 weeks

  2. Change and % change from baseline fasting glucose (serum and plasma)

    Measured: 13 weeks

  3. Change and % change from baseline seven point glucose profile

    Measured: 13 weeks

  4. Change and % change from baseline mean fasting and insulin c-peptide

    Measured: 13 weeks

  5. Change and % change from baseline fasting proinsulin

    Measured: 13 weeks

  6. Change and % change from baseline proinsulin / insulin ration

    Measured: 13 weeks

  7. Change and % change from baseline lipid and lipoprotein values: TC, LDL, HDL, TG, VLDL, apoB-100

    Measured: 13 weeks

  8. Change and % change from baseline Adiponectin

    Measured: 13 weeks

Secondary outcomes (5)

  1. Adverse Events

    Measured: 13 weeks

  2. Clinical laboratory tests

    Measured: 13 weeks

  3. 12 lead ECG

    Measured: 13 weeks

  4. vital signs assessments, weight change, physical exams

    Measured: 13 weeks

  5. concomitant medications

    Measured: 13 weeks

Timeline

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

  1. First posted3 Apr 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionMar 2009
  4. Study completionMay 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00455598
Sponsor's protocol ID
113715-CS14
Other IDs
EudraCT No: 2006-005718-11
Status last verified
Aug 2009
First submitted
2 Apr 2007
Last updated
28 Aug 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ISIS 113715 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 39 sites in 3 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 7 inclusion and 14 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 28 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Romania, Russia, Poland. 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. Some participants in this study may receive a placebo. 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?

Change and % change from baseline HbA1c (time frame: 13 weeks). The study lists 8 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 NCT00455598.

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 28 Aug 2009.

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