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Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes

2. april 2014 opdateret af: Novartis Pharmaceuticals

A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Evaluate Change in HbA1c After 12 Weeks Monotherapy With 7 Doses of LIK066 Compared With Placebo or Sitagliptin in Patients With Type 2 Diabetes

The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Confirmed diagnosis of T2DM by standard criteria
  2. Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
  3. Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1
  4. Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI)
  5. HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients
  6. HbA1c ≥ 7 to ≤ 9.5% at Visit 1 for patients treated with OAD monotherapy
  7. HbA1c ≥ 7 to ≤ 10.5% at Visit 199 for ALL patients
  8. Age: ≥18 and ≤ 75 years old at Visit 1
  9. BMI ≥22 to ≤45 kg/m2 at Visit 1

Exclusion Criteria:

  1. FPG ≥270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1
  2. Insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
  3. History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
  4. Significant lab abnormalities such as TSH outside of normal range, UACR>300 mg/g creatinine, eGFR <60 ml/min/1.73m2, hemoglobin <12 g/L in men and <11 g/L in women, hematuria
  5. ECG abnormalities including AV block, long QT syndrome or QTc>450 msec for men and >470 msec for women
  6. History of malignancy
  7. Women of child-bearing potential not using effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LIK066 2.5 mg
Patients receive 2.5 mg of LIK066 once daily for 12 weeks
Medicin: LIK066
Experimental treatment doses
Eksperimentel: LIK066 5 mg
Patients receive 5 mg of LIK066 once daily for 12 weeks
Medicin: LIK066
Experimental treatment doses
Eksperimentel: LIK066 10 mg
Patients receive 10 mg of LIK066 once daily for 12 weeks
Medicin: LIK066
Experimental treatment doses
Eksperimentel: LIK066 25 mg
Patients receive 25 mg of LIK066 once daily for 12 weeks
Medicin: LIK066
Experimental treatment doses
Eksperimentel: LIK066 50 mg
Patients receive 50 mg of LIK066 once daily for 12 weeks
Medicin: LIK066
Experimental treatment doses
Eksperimentel: LIK066 100 mg
Patients receive 100 mg of LIK066 once daily for 12 weeks
Medicin: LIK066
Experimental treatment doses
Eksperimentel: LIK066 150 mg
Patients receive 150 mg of LIK066 once daily for 12 weeks
Medicin: LIK066
Experimental treatment doses
Aktiv komparator: Sitagliptin 100 mg
Patients receive 100 mg sitagliptin once daily for 12 weeks
Medicin: Sitagliptin
Active comparator treatment dose
Placebo komparator: Placebo
Patients receive placebo for 12 weeks
Medicin: Placebo
Placebo comparator dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks
Tidsramme: baseline, 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo
baseline, 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Fasting Plasma Glucose
Tidsramme: baseline, 12 weeks
The effect of LIK066 on fasting plasma glucose after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in urinary glucose to creatinine ratio
Tidsramme: baseline, 12 weeks
The effect of LIK066 on urinary glucose to creatinine ratio after 12 weeks of treatment will be evaluated
baseline, 12 weeks
Change from baseline in Body weight
Tidsramme: baseline, 12 weeks
The effect of LIK066 on change in body weight after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in Blood pressure
Tidsramme: baseline, 12 weeks
The effect of LIK066 on change in systolic and diastolic blood pressure after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in postprandial glucose during a meal test
Tidsramme: baseline, 12 weeks
The effect of LIK066 on change in postprandial glucose during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in beta cell function during a meal test
Tidsramme: baseline, 12 weeks
The effect of LIK066 on change in beta cell function during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in insulin secretion relative to glucose during a meal test
Tidsramme: baseline, 12 weeks
The effect of LIK066on change in insulin secretion relative to glucose during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in oral glucose insulin sensitivity during a meal test
Tidsramme: baseline, 12 weeks
The effect of LIK066 on change in oral glucose insulin sensitivity during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in glucagon-like peptide response during a meal test
Tidsramme: baseline, 12 weeks
The effect of LIK066 on change in glucagon-like peptide during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Change from baseline in Peptide YY response during a meal test
Tidsramme: baseline, 12 weeks
The effect of LIK066 on change in peptide YY response during a meal test after 12 weeks of treatment will be evaluated.
baseline, 12 weeks
Number of patients with adverse events to assess safety and tolerability of LIK066
Tidsramme: 12 weeks
The safety and tolerability of 7 doses of LIK066 after 12 weeks of treatment will be evaluated with number of patients reported for total adverse events, serious adverse events and death.
12 weeks
Change from baseline in renal threshold for glucose excretion
Tidsramme: baseline, 12 weeks
The effect of LIK066 on renal threshold for glucose excretion will be calculated from glucose values in an overnight urine collection
baseline, 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2015

Primær færdiggørelse (Forventet)

1. november 2016

Studieafslutning (Forventet)

1. november 2016

Datoer for studieregistrering

Først indsendt

1. april 2013

Først indsendt, der opfyldte QC-kriterier

1. april 2013

Først opslået (Skøn)

4. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLIK066A2202
  • 2012-005793-63 (EudraCT nummer)

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Kliniske forsøg med Type 2 diabetes mellitus

Kliniske forsøg med Placebo

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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