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临床试验/NCT03596450
NCT03596450已完成4 期

Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Clinical Trial

Novo Nordisk A/S121 个研究点 分布在 1 个国家目标入组 1,278 人开始时间: 2018年7月13日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
1,278
试验地点
121
主要终点
Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting. The participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care antidiabetic medication (oral or injectable). The participant has an equal chance of being in either of the treatment groups. Neither the participant nor the study doctor or study staff will be able to pick which group the participant is in, but the participant will know which study drug the participant has been assigned to. The study doctor will provide the participant with a prescription for the study diabetes medication based on the treatment group the participant is assigned. The participation will last about 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
  • •Male or female, age 18 years or older at the time of signing informed consent.
  • •Type 2 diabetes mellitus diagnosis.
  • •Treatment with either 1 or 2 oral antidiabetic medications.
  • •Current member of a commercial or Medicare health plan with pharmacy benefits.
  • •Recorded HbAlc value within the last 90 days prior to randomization.
  • •Further intensification with an additional antidiabetic oral or injectable medication is indicated to achieve glycemic target at the discretion of the study physician according to approved labelling.

排除标准

  • •Previous randomization in this study
  • •Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of any type of insulin is allowed, as is prior insulin treatment for gestational diabetes.
  • •Contraindications to semaglutide according to the Food and Drug Administration approved label.
  • •Female who is pregnant, breastfeeding or intends to become pregnant
  • •Participation in another clinical trial.

研究组 & 干预措施

Semaglutide

Experimental

Participants will receive semaglutide subcutaneously (s.c.) in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.

干预措施: Semaglutide (Drug)

Standard of care

Active Comparator

Participants will receive standard of care in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.

干预措施: Standard of care (Drug)

结局指标

主要结局

Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No)

时间窗: At year 1

Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 1; No: number of participants who did not achieve HbA1c less than 7.0 % at year 1.

次要结局

  • Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No)(At year 2)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No)(At year 1)
  • Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No)(At year 1)
  • Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • DTSQc, Total Treatment Satisfaction Score Measured at Year 2(At year 2)
  • Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1(Baseline (less than or equal to 90 days prior to randomization at week 0), year 1)
  • Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No)(At year 1)
  • Change in Body Weight (in Pounds) From Baseline to Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years(Week 0 to year 2)
  • Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1(At year 1)
  • Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2(Baseline (less than or equal to 90 days prior to randomization at week 0), year 2)
  • Change From Baseline in SF-12 v2, PCS-12 Score at Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • Change From Baseline in WPAI-GH Activity Impairment Score at Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No)(At year 1)
  • Percentage Change in Body Weight From Baseline to Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • Percentage Change in Body Weight From Baseline to Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • Change in Systolic Blood Pressure (SBP) From Baseline to Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • Time to First Study Drug Discontinuation During 2 Years(Week 0 to year 2)
  • Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No)(At year 2)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No)(At year 2)
  • Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No)(Week 0 to year 1)
  • Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study(Week 0 to year 1)
  • Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No)(At year 1)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)(At year 1)
  • Change in Body Weight (in Pounds) From Baseline to Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • Change From Baseline in SF-12 v2, MCS-12 Score at Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No)(At year 2)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)(At year 2)
  • Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • Change From Baseline in WPAI-GH Activity Impairment Score at Year 1(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1)
  • All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2(From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2)
  • Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No)(At year 2)
  • Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No)(At year 2)
  • Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)(At year 2)
  • Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No)(At year 1)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No)(At year 2)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No)(At year 2)
  • Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study(Week 0 to year 2)
  • Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)(At year 1)
  • Change in Systolic Blood Pressure (SBP) From Baseline to Year 2(Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2)
  • Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No)(Week 0 to year 2)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No)(At year 1)
  • Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No)(At year 1)
  • Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No)(At year 2)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (121)

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