A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice (SURE GERMANY)

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04261933
• Collaborator: (none)
• Enrollment: 789
• Locations: 95
• Actual Duration (Months): 15.3
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: semaglutide

Study Design

• Study Type: Observational
• Actual Enrollment: 789 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes
• Actual Study Start Date: Feb 13, 2020
• Actual Primary Completion Date: May 25, 2021
• Actual Study Completion Date: May 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Semaglutide s.c. once-weekly Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks.	Drug: semaglutide; Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.

Outcome Measures

Primary Outcome Measures

1. Change in Glycated Haemoglobin A1c (HbA1c) [Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)]

   Percent point

2. Change in HbA1c [Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)]

   mmol/mol

Secondary Outcome Measures

1. Change in body weight (kg) [Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)]

   kg

2. Change in body weight (%) [Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)]

   Percent

3. Change in waist circumference [Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)]

   cm

4. HbA1c level below 8.0% (64 mmol/mol) (yes/no) [At end of study (week 28 to 38)]

   Number of participants

5. HbA1c level below 7.5% (59 mmol/mol) (yes/no) [At end of study (week 28 to 38)]

   Number of participants

6. HbA1c level below 7.0% (53 mmol/mol) (yes/no) [At end of study (week 28 to 38)]

   Number of participants

7. Reduction in HbA1c of 1.0% point or more (yes/no) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]

   Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more

8. Weight reduction of 3.0% or more (yes/no) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]

   Number of participants who achieved/not achieved weight reduction of 3.0% or more

9. Weight reduction of 5.0% or more (yes/no) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]

   Number of participants who achieved/not achieved weight reduction of 5.0% or more

10. HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]

    Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more

11. Patient reported severe or documented hypoglycaemia (yes/no) [Between baseline (week 0), end of study (week 28-38)]

    Count

12. Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction [Baseline (week 0), end of study (week 28 to 38)]

    The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively

13. Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction [Baseline (week 0), end of study (week 28 to 38)]

    The change version (DTSQc) has the same 8 items as the status version, but is reworded to direct the patients to compare the experience of the current treatment with the experience of previous treatment. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change

14. Change in score for Short Form (SF)-36 v2: Physical summary component [Baseline (week 0), end of study (week 28 to 38)]

    The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health).

15. Change in score for SF-36 v2: Mental summary component [Baseline (week 0), end of study (week 28 to 38)]

    The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health).

16. Patient completed the study under treatment with semaglutide (yes/no) [At end of study (week 28 to 38)]

    Count

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• • Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)

• The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study

• Male or female, age 18 years or older at the time of signing informed consent

• Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion

• Available and documented haemoglobin A1c (HbA1c) value equal to or below 12 weeks prior to initiation of semaglutide treatment

Exclusion Criteria:

• • Previous participation in this study. Participation is defined as having given informed consent in this study

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

• Treatment with any investigational drug within 90 days prior to enrolment into the study

• Hypersensitivity to semaglutide or to any of the excipients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Amberg		Germany	92224
2	Novo Nordisk Investigational Site	Aschaffenburg		Germany	63739
3	Novo Nordisk Investigational Site	Augsburg		Germany	86179
4	Novo Nordisk Investigational Site	Bad Mergentheim		Germany	97980
5	Novo Nordisk Investigational Site	Bad Oeynhausen		Germany	32549
6	Novo Nordisk Investigational Site	Bautzen		Germany	02625
7	Novo Nordisk Investigational Site	Berlin		Germany	10115
8	Novo Nordisk Investigational Site	Berlin		Germany	12247
9	Novo Nordisk Investigational Site	Berlin		Germany	13086
10	Novo Nordisk Investigational Site	Berlin		Germany	13597
11	Novo Nordisk Investigational Site	Berlin		Germany	14169
12	Novo Nordisk Investigational Site	Bernau bei Berlin		Germany	16321
13	Novo Nordisk Investigational Site	Bonn		Germany	53113
14	Novo Nordisk Investigational Site	Bramsche		Germany	49565
15	Novo Nordisk Investigational Site	Darmstadt		Germany	64283
16	Novo Nordisk Investigational Site	Dessau-Roßlau		Germany	06844
17	Novo Nordisk Investigational Site	Dresden		Germany	01277
18	Novo Nordisk Investigational Site	Dresden		Germany	01279
19	Novo Nordisk Investigational Site	Duisburg		Germany	47051
20	Novo Nordisk Investigational Site	Eisenach		Germany	99817
21	Novo Nordisk Investigational Site	Elsterwerda		Germany	04910
22	Novo Nordisk Investigational Site	Erdmannhausen		Germany	71729
23	Novo Nordisk Investigational Site	Erlangen		Germany	91052
24	Novo Nordisk Investigational Site	Essen		Germany	45279
25	Novo Nordisk Investigational Site	Essen		Germany	45335
26	Novo Nordisk Investigational Site	Forst (Lausitz)		Germany	03149
27	Novo Nordisk Investigational Site	Freisen		Germany	66629
28	Novo Nordisk Investigational Site	Friedrichsthal		Germany	66299
29	Novo Nordisk Investigational Site	Fulda		Germany	36037
30	Novo Nordisk Investigational Site	Gebhardshain		Germany	57580
31	Novo Nordisk Investigational Site	Gelnhausen		Germany	63571
32	Novo Nordisk Investigational Site	Grasleben		Germany	38368
33	Novo Nordisk Investigational Site	Großröhrsdorf		Germany	01900
34	Novo Nordisk Investigational Site	Grünstadt		Germany	67269
35	Novo Nordisk Investigational Site	Hainburg		Germany	63512
36	Novo Nordisk Investigational Site	Halle (Saale)		Germany	06128
37	Novo Nordisk Investigational Site	Hamburg		Germany	20097
38	Novo Nordisk Investigational Site	Hammelburg		Germany	97762
39	Novo Nordisk Investigational Site	Hannover		Germany	30165
40	Novo Nordisk Investigational Site	Heidenheim an der Brenz		Germany	89518
41	Novo Nordisk Investigational Site	Herrenberg		Germany	71083
42	Novo Nordisk Investigational Site	Hof		Germany	95030
43	Novo Nordisk Investigational Site	Hohenmölsen		Germany	06679
44	Novo Nordisk Investigational Site	Jena		Germany	07743
45	Novo Nordisk Investigational Site	Kempten (Allgäu)		Germany	87439
46	Novo Nordisk Investigational Site	Köln		Germany	50674
47	Novo Nordisk Investigational Site	Köln		Germany	50968
48	Novo Nordisk Investigational Site	Leipzig		Germany	04159
49	Novo Nordisk Investigational Site	Lichtenfels		Germany	96215
50	Novo Nordisk Investigational Site	Lingen		Germany	49808
51	Novo Nordisk Investigational Site	Ludwigsburg		Germany	71634
52	Novo Nordisk Investigational Site	Magdeburg		Germany	39104
53	Novo Nordisk Investigational Site	Marburg		Germany	35037
54	Novo Nordisk Investigational Site	Marburg		Germany	35039
55	Novo Nordisk Investigational Site	Mayen		Germany	56727
56	Novo Nordisk Investigational Site	Meckesheim		Germany	74909
57	Novo Nordisk Investigational Site	Mössingen		Germany	72116
58	Novo Nordisk Investigational Site	Mühldorf Am Inn		Germany	84453
59	Novo Nordisk Investigational Site	Mülheim		Germany	45468
60	Novo Nordisk Investigational Site	München		Germany	80331
61	Novo Nordisk Investigational Site	München		Germany	81477
62	Novo Nordisk Investigational Site	Münster		Germany	48153
63	Novo Nordisk Investigational Site	Neustrelitz		Germany	17235
64	Novo Nordisk Investigational Site	Nürnberg		Germany	90480
65	Novo Nordisk Investigational Site	Oranienburg		Germany	16515
66	Novo Nordisk Investigational Site	Osnabrück		Germany	49080
67	Novo Nordisk Investigational Site	Otterbach		Germany	67731
68	Novo Nordisk Investigational Site	Pohlheim		Germany	35415
69	Novo Nordisk Investigational Site	Rellingen		Germany	25462
70	Novo Nordisk Investigational Site	Rostock		Germany	18109
71	Novo Nordisk Investigational Site	Saint Ingbert-Oberwürzbach		Germany	66386
72	Novo Nordisk Investigational Site	Schorndorf		Germany	73614
73	Novo Nordisk Investigational Site	Schwerin		Germany	19053
74	Novo Nordisk Investigational Site	Schönhausen (Elbe)		Germany	39524
75	Novo Nordisk Investigational Site	Seelow		Germany	15306
76	Novo Nordisk Investigational Site	Soltau		Germany	29614
77	Novo Nordisk Investigational Site	Sonsbeck		Germany	47665
78	Novo Nordisk Investigational Site	Speyer		Germany	67346
79	Novo Nordisk Investigational Site	Spremberg		Germany	03130
80	Novo Nordisk Investigational Site	Stadtbergen		Germany	86391
81	Novo Nordisk Investigational Site	Straubing		Germany	94315
82	Novo Nordisk Investigational Site	Stuttgart		Germany	70184
83	Novo Nordisk Investigational Site	Stuttgart		Germany	70378
84	Novo Nordisk Investigational Site	Trier		Germany	54292
85	Novo Nordisk Investigational Site	Ulm		Germany	89073
86	Novo Nordisk Investigational Site	Viersen		Germany	41747
87	Novo Nordisk Investigational Site	Villingen-Schwenningen		Germany	78048
88	Novo Nordisk Investigational Site	Villingen-Schwenningen		Germany	78054
89	Novo Nordisk Investigational Site	Wedemark		Germany	30900
90	Novo Nordisk Investigational Site	Wetzlar		Germany	35578
91	Novo Nordisk Investigational Site	Wiesloch		Germany	69168
92	Novo Nordisk Investigational Site	Witzenhausen		Germany	37213
93	Novo Nordisk Investigational Site	Wolmirstedt		Germany	39326
94	Novo Nordisk Investigational Site	Wurzen		Germany	04808
95	Novo Nordisk Investigational Site	Zwenkau		Germany	04442

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor & Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04261933
• Other Study ID Numbers: NN9535-4617; U1111-1241-6291
• First Posted: Feb 10, 2020
• Last Update Posted: Jul 26, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 26, 2021