A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

Sponsor
Allergan (Industry)
Overall Status
Terminated
CT.gov ID
NCT03383146
Collaborator
(none)
450
349
2
33.1
1.3
0

Study Details

Study Description

Brief Summary

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Nov 5, 2020
Actual Study Completion Date :
Nov 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.

Drug: Placebo
Placebo injected subcutaneously twice daily.

Experimental: Relamorelin 10 μg

Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.

Drug: Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily.

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study]

    Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

  2. Change From Baseline to Week 52 in the Weekly Average DGSSS [Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study]

    Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

  3. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)]

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.

  4. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [Up to 52 weeks]

    Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  5. Number of Participants With Clinically Meaningful Trends for Vital Signs [Up to 52 weeks]

    Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.

  6. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [Up to 52 weeks]

    A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

  7. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c) [Up to 52 weeks]

  8. Number of Participants With Anti-relamorelin Antibody Testing Results by Visit [Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)]

    A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Two different groups of participants may enter into the study:
  1. Rollover Participants

Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:

•In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:

  • They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR

  • They had vomiting episodes and an average daily DGSSS of ≥12 but <16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device

  1. De Novo Participants
  • Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%

  • DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)

  • Compliance with the entry of data into the hand-held electronic device during the Run-in Period

  • Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period

  • The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12

Exclusion Criteria:
  1. Both Rollover and De Novo Participants

•Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)

  1. Rollover Participants

•Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria

  1. De Novo Participants
  • History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit

  • History of intestinal malabsorption or pancreatic exocrine insufficiency

  • History of belching disorders, other nausea and vomiting disorders

  • Gastric or duodenal ulcer within 3 months of Screening

  • History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer

  • Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression

  • Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period

  • Currently taking opiates, or expecting to use opiates during the course of the clinical study

  • Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period

  • History of pyloric injection of botulinum toxin within 6 months of screening

  • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)

  • Randomization in any previous study in which relamorelin was a treatment

  • Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pinnacle Research Group Anniston Alabama United States 36207
2 North Alabama Research Center, LLC Athens Alabama United States 35611
3 Simon Williamson Clinic Birmingham Alabama United States 35211
4 Digestive Health Specialist of the South East Dothan Alabama United States 36305
5 G & L Research, LLC Foley Alabama United States 36535
6 Avant Research Associates Huntsville Alabama United States 35801
7 Alabama Medical Group, PC Mobile Alabama United States 36608
8 Phoenix Clinical LLC. Phoenix Arizona United States 85014
9 Del Sol Research Management, LLC Tucson Arizona United States 85710
10 Del Sol Research Management, LLC Tucson Arizona United States 85712
11 Synexus Clinical Research US, Inc. Tucson Arizona United States 85741
12 Preferred Research Partners, Inc. Little Rock Arkansas United States 72211
13 Applied Research Center of Arkansas Little Rock Arkansas United States 72212
14 Arkansas Gastroenterology North Little Rock Arkansas United States 72117
15 Unity Health - Searcy Medical Center Searcy Arkansas United States 72143
16 Hope Clinical Research Canoga Park California United States 91303
17 GW Research Inc Chula Vista California United States 91910
18 Kindred Medical Institute for Clinical Trials, LLC Corona California United States 92879
19 Aurora Care Clinic, LLC Costa Mesa California United States 92627
20 TriWest Research Associates El Cajon California United States 92020
21 Diagnamics Inc. Encinitas California United States 92024
22 VVCRD Research Garden Grove California United States 92845
23 University of California San Diego La Jolla California United States 92037
24 Om Research LLC Lancaster California United States 93534
25 Torrance Clinical Research Institute, Inc. Lomita California United States 90717
26 Angel City Research Inc. Los Angeles California United States 90057
27 Stanford Hospital Palo Alto California United States 94304
28 Optimal Research California San Diego California United States 92108
29 Medical Associates Research Group, Inc San Diego California United States 92123
30 Syrentis Clinical Research Santa Ana California United States 92705
31 Upland Clinical Research Upland California United States 91786
32 Synexus Clinical Research US, Inc. Vista California United States 92083
33 New Hope Research Development Whittier California United States 90603
34 Peak Gastroenterology Associates Colorado Springs Colorado United States 80907
35 Synexus Colorado Springs Colorado United States 80909
36 Gastroenterology Associates of Fairfield County, P.C. Bridgeport Connecticut United States 06606
37 Medical Research Center of Connecticut, LLC Hamden Connecticut United States 06518
38 Innovative Research of West FL, Inc. Clearwater Florida United States 33756
39 Clinical Research of West Florida Clearwater Florida United States 33765
40 ALL Medical Research, LLC Cooper City Florida United States 33024
41 Top Medical Research Cutler Bay Florida United States 33189
42 Palmetto Research, LLC Hialeah Florida United States 33016
43 Vida Clinical Trials Homestead Florida United States 33030
44 Nature Coast Clinical Research Inverness Florida United States 34452
45 Savin Medical Group LLC Miami Lakes Florida United States 33014
46 APF Research LLC Miami Florida United States 33134
47 AMPM Research Clinic Miami Florida United States 33169
48 Advanced Medical Research Institute Miami Florida United States 33174
49 Florida Research Center, Inc. Miami Florida United States 33174
50 American Research Institute, Inc Miami Florida United States 33175
51 Gastroenterology Group of Naples Naples Florida United States 34102
52 Sensible Healthcare Ocoee Florida United States 34761
53 Synexus Pinellas Park Florida United States 33781
54 Atlanta Diabetes Associates Atlanta Georgia United States 30318
55 River Birch Research Alliance, LLC Blue Ridge Georgia United States 30513
56 Gwinnett Research Institute, LLC Buford Georgia United States 30519
57 Summit Clinical Research, LLC. Carnesville Georgia United States 30521
58 iResearch Atlanta LLC Decatur Georgia United States 30030
59 Infinite Clinical Trials Riverdale Georgia United States 30274
60 Clinical Research Consultants of Atlanta Suwanee Georgia United States 30024
61 Rocky Mountain Diabetes and Osteoporosis Center, PA Idaho Falls Idaho United States 83404-7596
62 North Shore University Health System Evanston Illinois United States 60201
63 Southwest Gastroenterology Oak Lawn Illinois United States 60453
64 MediSphere Medical Research Center, LLC Evansville Indiana United States 47714
65 Synexus Clinical Research US, Inc. Evansville Indiana United States 47714
66 American Research, LLC Jeffersonville Indiana United States 47130
67 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
68 University of Kansas Medical Center Kansas City Kansas United States 66160
69 Health Science Research Center Pratt Kansas United States 67124
70 WestGlen Gastrointestinal Consultants Shawnee Mission Kansas United States 66217
71 Cotton-O'Neil Clinical Research Center - Digestive Health Topeka Kansas United States 66606
72 Kansas Medical Clinic Topeka Kansas United States 66606
73 Professional Research Network of Kansas, LLC Wichita Kansas United States 67205
74 Via Christi Clinic, PA Wichita Kansas United States 67208
75 St. Elizabeth Healthcare â€" Clinical Research Institute Erlanger Kentucky United States 41018
76 University of Louisville Louisville Kentucky United States 40202
77 WK Physicians Network Bossier City Louisiana United States 71111
78 Avant Research Associates LLC Crowley Louisiana United States 70526
79 Cronola LLC Houma Louisiana United States 70360
80 Clinical Trials of SWLA, LLC Lake Charles Louisiana United States 70601
81 Tandem Clinical Research Marrero Louisiana United States 70072
82 Clinical Trials of America, Inc. West Monroe Louisiana United States 71291
83 Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research Chevy Chase Maryland United States 20815
84 Gastro Center of Maryland Columbia Maryland United States 21045
85 Frederick Gastroenterology Associates, PA an Elligo Health Research Site Frederick Maryland United States 21701
86 Woodholme Gastroenterology Associates, P.A. Glen Burnie Maryland United States 21061
87 Meritus Center for Clinical Research Hagerstown Maryland United States 21742
88 Meridian Clinical Research, LLC Rockville Maryland United States 20854
89 Clinical Research Institute of Michigan Chesterfield Michigan United States 48047
90 Vida Clinical Studies Dearborn Michigan United States 48124
91 Aa Mrc, Llc Flint Michigan United States 48504
92 National Clinical, LLC Hamtramck Michigan United States 48212
93 Gastroenterology Associates of Western Michigan, West Michigan Clinical Research Center Wyoming Michigan United States 49519
94 MNGI Digestive Health Coon Rapids Minnesota United States 55446
95 Synexus Clinical Research US, Inc. Richfield Minnesota United States 55423
96 Synexus Clinical Research US, Inc Saint Louis Missouri United States 63141
97 Montana Medical Research Missoula Montana United States 59808
98 Diabetes and Endocrine Associates, P.C. Omaha Nebraska United States 68114
99 Heartland Clinical Research, Inc Omaha Nebraska United States 68134
100 Excel Clinical Research Las Vegas Nevada United States 89109
101 Clinical Research of South Nevada - CROSN Las Vegas Nevada United States 89121
102 Advanced Biomedical Research of America Las Vegas Nevada United States 89123
103 Digestive Disease Specialists Las Vegas Nevada United States 89128
104 Palm Research Center Las Vegas Nevada United States 89135
105 Garden State Endocrinology LLC Brick New Jersey United States 08723
106 Synexus Clinical Research US, Inc. Bridgeton New Jersey United States 08302
107 AGA Clinical Research Associates, LLC Egg Harbor Township New Jersey United States 08234
108 Lovelace Scientific Resources, Inc. Albuquerque New Mexico United States 87108
109 CHEAR Center LLC Bronx New York United States 10455
110 Long Island Gastrointestinal Research Group LLP Great Neck New York United States 11023
111 United Health Services Hospitals, Inc. Johnson City New York United States 13790
112 Asheville Gastroenterology Associates Asheville North Carolina United States 28801
113 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599-7080
114 Carolinas Healthcare-Charlotte Charlotte North Carolina United States 28204
115 Carolina Digestive Health Associates, PA Concord North Carolina United States 28025
116 Cumberland Research Associates, LLC Fayetteville North Carolina United States 28304
117 Triad Clinical Trials Greensboro North Carolina United States 27410
118 Vidant Multispeciality Clinic - Kinston Kinston North Carolina United States 28501
119 Diabetes and Endocrinology Consultants, PC Morehead City North Carolina United States 28557
120 PMG Research Salisbury Salisbury North Carolina United States 28144
121 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
122 Trial Management Associates, LLC Wilmington North Carolina United States 28403
123 PMG Research of Winston-Salem, LLC Winston-Salem North Carolina United States 27103
124 The Center for Clinical Research Winston-Salem North Carolina United States 27103
125 Synexus Clinical Research US, Inc. Akron Ohio United States 44311
126 Dayton Gastroenterology,Inc. Beavercreek Ohio United States 45440
127 Diabetes & Endocrinology Associates of Stark County, Inc. Canton Ohio United States 44718
128 Synexus Clinical Research US - Cincinnati Cincinnati Ohio United States 45236
129 Synexus Clinical Research US, Inc Cincinnati Ohio United States 45249
130 Endocrinology Research Associates, Inc. Columbus Ohio United States 43201
131 The Ohio State University, Wexner Medical Center Columbus Ohio United States 43203
132 Aventiv Research, Inc. Columbus Ohio United States 43213
133 Hometown Urgent Care and Research Columbus Ohio United States 43214
134 CIC America Clinical Inquest Center Ltd. Dayton Ohio United States 45409
135 Hometown Urgent Care and Research Dayton Ohio United States 45424
136 Premier Clinical Research d.b.a. STAT Research Franklin Ohio United States 45005
137 Family Practice Center of Wadsworth, Inc. Wadsworth Ohio United States 44281
138 Centennial Health-Synexus Oklahoma City Oklahoma United States 73111
139 Digestive Disease Specialists Inc Oklahoma City Oklahoma United States 73112
140 Memorial Clinical Research Oklahoma City Oklahoma United States 73120
141 Options Health Research, LLC Tulsa Oklahoma United States 74104
142 Northwest Gastroenterology Clinic, LLC Portland Oregon United States 97210
143 Family Medical Associates, Research Department Levittown Pennsylvania United States 19056
144 Allegheny Endocrinology Associates Pittsburgh Pennsylvania United States 15212
145 Preferred Primary Care Physicians, Inc. Pittsburgh Pennsylvania United States 15236
146 Guthrie Clinical Research Sayre Pennsylvania United States 18840
147 Frontier Clinical Research, LLC Scottdale Pennsylvania United States 15683
148 Frontier Clinical Research, LLC Smithfield Pennsylvania United States 15478
149 Preferred Primary Care Physicians Uniontown Pennsylvania United States 15401
150 Synexus Clinical Research US, Inc. Anderson South Carolina United States 29621
151 Synexus Clinical Research US, Inc Anderson South Carolina United States 29621
152 Clinical Trials of South Carolina Charleston South Carolina United States 29406
153 Carolina Medical Research Clinton South Carolina United States 29325
154 Gastroenterology Associates, PA Greenville South Carolina United States 29615
155 Synexus Clinical Research Greer South Carolina United States 29650
156 Health Concepts Rapid City South Dakota United States 57702
157 Clinsearch Chattanooga Tennessee United States 37421
158 Gastroenterology Centers of the Midsouth Germantown Tennessee United States 38138
159 East Tennessee Research Institute Johnson City Tennessee United States 37604
160 Quality Medical Research Nashville Tennessee United States 37211
161 Texas Clinical Research Institute, LLC Arlington Texas United States 76012
162 DiscoveResearch, Inc. Beaumont Texas United States 77701
163 ClinRx Research, LLC Carrollton Texas United States 75007
164 Baylor College of Medicine Medical Center Houston Texas United States 77030
165 Biopharma Informatic Inc., Research Center Houston Texas United States 77043
166 Houston Endoscopy and Research Center, Inc. Houston Texas United States 77079
167 Rodriguez Clinical Trials Houston Texas United States 77083
168 Amir Hassan, MD, PA Houston Texas United States 77089
169 Sante Clinical Research Kerrville Texas United States 78028
170 Pinnacle Clinical Research San Antonio Texas United States 78215
171 Clinical Trials of Texas, Inc. San Antonio Texas United States 78229
172 Sagact Pllc. San Antonio Texas United States 78229
173 Synexus Clinical Research US, Inc. San Antonio Texas United States 78229
174 Synexus Clinical Research US, Inc. Layton Utah United States 84041
175 Synexus Clinical Research US, Inc. Murray Utah United States 84123
176 Advanced Research Institute, Inc. Ogden Utah United States 84405
177 Advanced Clinical Research West Jordan Utah United States 84088
178 Verity Research Inc. Fairfax Virginia United States 22031
179 Blue Ridge Medical Research Lynchburg Virginia United States 24502
180 Manassas Clinical Research Centre Manassas Virginia United States 20110
181 VA Medical Center McGuire VAMC Richmond Virginia United States 23249
182 Washington Gastroenterology PLLC Tacoma Washington United States 98405
183 West Virginia University Morgantown West Virginia United States 26506
184 Consultorios Asociados de Endocrinologia e Investigación Cl Buenos Aires Buenos Aires Province Argentina C1425AGC
185 Hospital Sirio Libanes Caba Buenos Aires Province Argentina C1419AHN
186 Centro de Investigaciones Medicas Mar del Plata SRL Mar del Plata Buenos Aires Argentina B7600FYK
187 CIPREC Buenos Aires Ciudad Autonoma deBuenos Aires Argentina 1119
188 Instituto de Investigaciones Clinicas de Rosario Rosario Santa Fe Argentina S2000BIE
189 Instituto Medico Catamarca-I.ME.C Rosario Santa Fe Argentina S200CFK
190 Clinica Mayo de Urgencias Medicas Cruz Blanca SRL San Miguel de Tucuman Tucuman Argentina 4000
191 CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian Cordoba Argentina X5000BNB
192 Centro Universitario de Investigacion en Farmacologia Clinic Corrientes Argentina W3410AVV
193 Instituto Privado de Investigaciones Clinicas de Cordoba Córdoba Argentina X5000AAW
194 Nepean Hospital Kingswood New South Wales Australia 2747
195 Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated Adelaide South Australia Australia 5000
196 Royal Melbourne Hospital Parkville Victoria Australia 3050
197 Ordination Osterreicher Steiermark Austria 8511
198 VIVIT Institute, am LKH Feldkirch Feldkirch Vorarlberg Austria 6807
199 Privatklinik wehlre-Diakonissen Salzburg Austria 5020
200 Oö. Gesundheits- und Spitals-AG/LKH Steyr Steyr Austria 4400
201 Universitair Ziekenhuis Antwerpen, Gastro-Enterologie, Edegem Antwerp Belgium 2650
202 UZ Brussel Jette Brussel Belgium 1090
203 AZ Sint Lucas Brugge Brugge West-Vlaanderen Belgium 8310
204 Hospital Universitário Walter Cantídio Fortaleza CE Brazil 60430-270
205 Centro de Pesquisa Clinica do Brasil Brasilia Distrito Federal Brazil 71625175
206 Hospital Universitário João de Barros Barreto - UFPA Belem PA Brazil 66073-005
207 Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Rio Grande Do Sul Brazil 90430-001
208 Instituto Catarinense de Endocrinologia e Diabetes (ICED) Joinville Santa Catarina Brazil 89201-260
209 Scentryphar Pesquisa Clínica Ltda Campinas Sao Paulo Brazil 13020-431
210 Instituto de Pesquisa Clinica em Campinas Campinas Sao Paulo Brazil 13060-080
211 Instituto de Estudos e Pesquisas Clinicas do Ceara IEP/CE - Oncology Fortaleza Brazil 60160-230
212 IPEC-Instituto de Pesquisa Clinica Sao Paulo Brazil 01223-001
213 CPQuali Pesquisa Clinica Ltda Sao Paulo Brazil 01228-000
214 MHAT Yuliya Vrevska Byala Byala Ruse Bulgaria 7100
215 UMHAT - Kaspela- EOOD Plovdiv Bulgaria 4002
216 Medical Center Asklepion - Humane Medicine Research EOOD Sofia Bulgaria 1303
217 Alexandrovska University Hospital Sofia Bulgaria 1431
218 University of Calgary Calgary Alberta Canada T2N 2T9
219 Central Alberta Research Centre Red Deer Alberta Canada T4N 6V7
220 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
221 Patient research centre St. John's Newfoundland and Labrador Canada A1B 3V6
222 South Shore Medical Arts Bridgewater Nova Scotia Canada B4V 3N2
223 The Ottawa Hospital Ottawa Ontario Canada K1H 7W9
224 Toronto Digestive Disease Associates, Inc. Vaughan Ontario Canada L4L 4Y7
225 Recherche GCP Research Montreal Quebec Canada H1M 1B1
226 Centro Cardiovascular Colombiano Clínica Santa María Medellin Antioquia Colombia 050034
227 Rodrigo Botero S.A.S. Medellín Antioquia Colombia 050030
228 Centro Cardiovascular y de Diabetes Barranquilla Atlantico Colombia 080020
229 Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS Barranquilla Atlantico Colombia 080020
230 Asociación Colombiana de Diabetes Bogotá Cundinamarca Colombia 111311
231 Healthy Medical Center Zipaquira Cundinamarca Colombia 250252
232 Endocare Ltda. Bogotá Distrito Capital De Bogotá Colombia 111111
233 Medplus Centro de Recuperacion Integral S.A.S. Bogotá Distrito Capital Colombia 110221
234 Centro de Investigaciones Clínicas IPS CARDIOMET Pereira Pereira Risaralda Colombia 660003
235 IPS Centro Medico Julian Coronel S.A Cali Valle Del Cauca Colombia 760035
236 Centro Medico Imbanaco de Cali S.A. Cali Valle Del Cauca Colombia 760042
237 Steno Diabetes Center Copenhagen Hellerup Copenhagen Denmark 2900
238 Gastroenheden, Hvidovre hospital Hvidovre København Denmark 2605
239 Klinische Forschung Karlsruhe GmbH Karlsruhe Baden-Wurttemberg Germany 76199
240 Studienzentrum Schwittay Böhlen Saxony Germany 4564
241 Klinische Forschung Dresden GmbH Dresden Saxony Germany 1309
242 Clinical Research Hamburg Hamburg Germany 22143
243 Israelitisches Krankenhaus Hamburg Germany 22297
244 KRH Klinikum Siloah Hannover Germany 30459
245 Markhot Ferenc Oktatokorhaz es Rendelointezet Eger Heves Hungary H-3300
246 Hetenyi Geza Hospital Szolnok Jász-Nagykun-Szolnok Hungary H-5004
247 Zala Megyei Szent Rafael Korhaz Zalaegerszeg Zala Hungary H-8900
248 Strázsahegy Gyógyszertár Medicina Budapest Hungary H1171
249 Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika Szeged Hungary H-6720
250 Kumudini Devi Diabetes Research Center; Ramdevrao Hospital Hyderabad Andhra Pradesh India 500072
251 King George Hospital Visakhapatnam Andhra Pradesh India 530002
252 Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology Ahmedabad Gujarat India 380007
253 Zydus Hospital Ahmedabad Gujarat India 380054
254 Lifecare Clinic and Research Centre - Internal Med/Diabetology Bangalore Karnataka India 560092
255 Diacon Hospital and research Center - Diabetology Bengaluru Karnataka India 359-360
256 Victoria Hospital Bangalore Medical College and Research Institute Bengaluru Karnataka India 560002
257 Rajalakshmi Hospital Bengaluru Karnataka India 560097
258 Bhatia Hospital Mumbai Maharashtra India 400007
259 B. J. Government Medical College and Sassoon General Hospitals Pune Maharashtra India 411001
260 Universal Hospital Pune Maharashtra India 411011
261 Noble Hospital Pune Maharashtra India 411013
262 S R Kalla (SRK) Memorial Gastro & General Hospital Jaipur Rajasthan India 302001
263 Marudhar Hospital Jaipur Rajasthan India 302012
264 Eternal Hospital - Diabetology Jaipur Rajasthan India 302017
265 SMS Hospital Jaipur Rajasthan India 302017
266 M.V. Hospital for Diabetes & Diabetes Research Centre Chennai Tamil Nadu India 600013
267 Kovai Diabetes Speciality Centre Coimbatore Tamil Nadu India 641009
268 Arthur Asirvatham Hospital Madurai Tamil Nadu India 625020
269 M V Hospital & Research Centre Lucknow Uttar Pradesh India 226003
270 Sir Ganga Ram Hospital (SGRH) Delhi India 110060
271 Vinaya Hospital & Research Centre Mangalore India 575003
272 Bnei-Zion MC Haifa Israel 31948
273 Chonbuk National University Hospital Jeonju Jeollabuk-Do Korea, Republic of 561-712
274 Sanggye Paik Hospital, Inje University College of Medicine Seoul Nowon-gu Korea, Republic of 1757
275 Asan Medical Center Seoul Korea, Republic of 05505
276 Kraslava Hospital Kraslava Kraslavas Nov. Latvia 5601
277 Polana-D Daugavpils Latvia LV5401
278 Pauls Stradins Clinical University Hospital, Endokrinologijas nodala Riga Latvia 1002
279 Digestive Diseases Centre GASTRO Riga Latvia 1006
280 Hospital Sultanah Bahiyah Alor Setar Kedah Malaysia 5460
281 Clinical Investigation Centre Kuala Lumpur Malaysia 59100
282 Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital Universiti Sains Malaysia Kubang Kerian Malaysia 16150
283 Hospital Taiping Taiping Malaysia 34000
284 Mentrials Sa de Cv Mexico DF Distrito Federal Mexico 06700
285 Clinicos Asociados BOCM SC Mexico Distrito Federal Mexico 03300
286 Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology Mexico Distrito Federal Mexico 11650
287 Centro de Atención e Investigación en Factores de Riesgo Car Mexico Distrito Federal Mexico 14000
288 Unidad de Investigacion Clinica Cardiometabolica de Occidente Guadalajara Jalisco Mexico 44150
289 Consultorio particular Guadalajara Jalisco Mexico 44210
290 Unidad de Investigación Clínica en Medicina S.C/ Guadalajara Jalisco Mexico 44670
291 Centro de Desarrollo Biomédico S.C.P Mérida Yucatán Mexico 97070
292 Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV Aguascalientes Mexico 20230
293 Hospital Cardiologica Aguascalientes Aguascalientes Mexico 20230
294 Dioderm Instituto de Investigacion Durango Mexico 34060
295 CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición) Durango Mexico 34270
296 Sociedad de Metabolismo y Corazon S.C. Veracruz Mexico 91900
297 West Visayas State University Medical Center IloIlo City IloIlo Philippines 5000
298 Cardinal Santos Medical Center San Juan City Metro Manila Philippines 1502
299 Manila Doctors Hospital, Ermita Manila Metropolitan Manila Philippines 1000
300 San Juan De Dios Educational Foundation, Inc. Pasay Metropolitan Manila Philippines 1300
301 Ospital ng Makati Makati City NCR Philippines 1218
302 Perpetual Succor Hospital Cebu City Philippines 6000
303 St. Luke's Medical Center Quezon City Philippines 1100
304 Specjalistyczny Gabinet Neurologiczny Marta Banach Kraków Lesser Poland Poland 30-539
305 CenterMed Krakow Ltd Krakow Malopolska Poland 31-530
306 Centrum Medyczne Lukamed Chojnice Poland 89-600
307 Saint-Petersburg City Pokrovskaya Hospital St-Petersburg Leningrad Region Russian Federation 199106
308 GUZ Saratov City Clinical Hospital 9 Saratov Saratov Region Russian Federation 410030
309 Scientific Institute of Clinical and Experimental Lymphology Novosibirsk Russian Federation 630117
310 Rostov on Don Rostov on Don Russian Federation 344019
311 National University Hospital Singapore Singapore 119228
312 Changi General Hospital Singapore Singapore 529889
313 Singapore General Hospital Singapore Singapore S169856
314 FARMOVS Bloemfontein Free State South Africa 9301
315 Wits Clinical Research Johannesburg Gauteng South Africa 2193
316 Synexus Stanza Clinical Research Centre Pretoria Gauteng South Africa 0122
317 Watermeyer Clinical Research Site Pretoria Val De Grace South Africa 0184
318 Synexus Helderberg Clinical Research Centre Somerset West South Africa 7130
319 Hospital Universitario Principe de Asturias Madrid Spain 28850
320 Phramongkutklao Hospital Bangkok Thailand 10400
321 Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok Thailand 10700
322 Maharaj Nakorn Chiang Mai Hospital Chiang Mai Thailand 50200
323 State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine Dnipro Dnipropetrovs'ka Oblast' Ukraine 49027
324 Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia Zaporizhzhia Zaporizhzhia Region Ukraine 69600
325 Chernivtsi Regional Clinical Hospital Chernivtsi Ukraine 58001
326 Regional Municipal noncommercial Enterprise "Chernivtsi Regional Endocrinology Center", Polyclinic department, Higher State Educational Establishment of Ukraine "Bukovinian State Medical University", Department of Clinical Immunology, Allergology and Endo Chernivtsi Ukraine 58022
327 Ivano-Frankivsk National Medical University Ivano-Frankivsk Ukraine 76008
328 Ivano-Frankivsk Central City Clinical Hospital Ivano-Frankivsk Ukraine 76018
329 Municipal nonprofit entity of Kharkiv municipal council Kharkiv Ukraine 61037
330 Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine" Kharkiv Ukraine 61070
331 Communal Institution Kherson City Clinical Hospital Kherson Ukraine 73000
332 Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department Kyiv Ukraine 3049
333 Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit Kyiv Ukraine 4050
334 Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University Odesa Ukraine 65010
335 Poltava Regional Clinical Hospital Poltava Ukraine 36011
336 Private Small-Scale Enterprise Medical Centre Pulse Vinnytsia Ukraine 21001
337 Vinnytsia Regional Clinical highly specialized Endocrinology Centre Vinnytsia Ukraine 21010
338 Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology Zaporizhzhia Ukraine 69035
339 Biomedical Research Centre Nottingham East Midland United Kingdom NG7 2UH
340 MAC Clinical Research Manchester Manchester Greater Manchester United Kingdom M13 9NQ
341 Royal Oldham Hospital Oldham Lancashire United Kingdom OL1 2JH
342 MAC Clinical Research Liverpool Merseyside United Kingdom L34 1BH
343 MAC Research, Exchange House Cannock Staffordshire United Kingdom WS11 0BH
344 University Hospitals of North Midlands Stoke on Trent Staffordshire United Kingdom ST6 8DG
345 MAC Clinical Research, Monarch House Leeds West Yorkshire United Kingdom LS10 1DU
346 MAC Research Barnsley United Kingdom S75 3DL
347 MAC Clinical Research, Kaman Court Blackpool United Kingdom FY2 0JH
348 Mid Essex Hospital Services NHS Trust Broomfield Hospital Chelmsford United Kingdom CM1 7ET
349 MAC Clinical Research, GAC House Manchester United Kingdom M13 9NQ

Sponsors and Collaborators

  • Allergan

Investigators

  • Study Director: Harvy Schneier, Allergan

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03383146
Other Study ID Numbers:
  • RLM-MD-04
  • 2017-002144-33
First Posted:
Dec 26, 2017
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Allergan
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Participants who completed the placebo run-in of relamorelin studies: RLM-MD-01 [NCT03285308] and RLM-MD-02 [NCT03426345] were eligible to rollover to this study. De novo (New) participants, who had not participated in the previous studies, were also eligible for enrollment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Period Title: Overall Study
STARTED 148 302
Safety Population 145 299
Run-in Period 91 207
COMPLETED 63 118
NOT COMPLETED 85 184

Baseline Characteristics

Arm/Group Title Placebo Relamorelin 10 μg Total
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Total of all reporting groups
Overall Participants 148 302 450
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
57.0
(12.37)
57.9
(11.57)
57.6
(11.84)
Sex: Female, Male (Count of Participants)
Female
102
68.9%
224
74.2%
326
72.4%
Male
46
31.1%
78
25.8%
124
27.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
50
33.8%
82
27.2%
132
29.3%
Not Hispanic or Latino
98
66.2%
220
72.8%
318
70.7%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
7
4.7%
11
3.6%
18
4%
Asian
0
0%
9
3%
9
2%
Native Hawaiian or Other Pacific Islander
1
0.7%
0
0%
1
0.2%
Black or African American
27
18.2%
53
17.5%
80
17.8%
White
109
73.6%
218
72.2%
327
72.7%
More than one race
4
2.7%
11
3.6%
15
3.3%
Unknown or Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Description Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.
Time Frame Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study

Outcome Measure Data

Analysis Population Description
Modified-intent-to-treat (mITT) Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Measure Participants 147 295
Baseline
20.3
(6.70)
19.7
(6.39)
Change from Baseline to Week 12
-7.1
(8.82)
-6.5
(7.80)
2. Primary Outcome
Title Change From Baseline to Week 52 in the Weekly Average DGSSS
Description Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.
Time Frame Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study

Outcome Measure Data

Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Measure Participants 147 295
Baseline
20.3
(6.70)
19.7
(6.39)
Change from Baseline to Week 52
-10.7
(8.93)
-8.6
(8.92)
3. Primary Outcome
Title Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Description An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Time Frame First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Measure Participants 145 299
Count of Participants [Participants]
105
70.9%
221
73.2%
4. Primary Outcome
Title Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Description Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time Frame Up to 52 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of study treatment. Number analyzed is the number of participants with non-PCS Baseline values and at least one post-baseline assessment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Measure Participants 145 299
Hematocrit (RATIO): >1.1×Upper Limit of Normal Value (ULN)
0
0%
1
0.3%
Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN)
5
3.4%
14
4.6%
Hemoglobin (gram(g)/L): <0.9×LLN
10
6.8%
20
6.6%
Lymphocytes Absolute Cell Count (10^9/(Liter(L)): >1.5×ULN
1
0.7%
5
1.7%
Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN
2
1.4%
9
3%
Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN
2
1.4%
2
0.7%
Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN
2
1.4%
0
0%
Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN
7
4.7%
3
1%
Red Blood Cell Count (10^12/L):<0.9×LLN
2
1.4%
10
3.3%
White Blood Cell Count (10^9/L): <0.7×LLN
2
1.4%
0
0%
Alanine Aminotransferase (Serum Glutamate-Pyruvate transaminase (SGPT)) (Unit (U)/L): ≥3.0×ULN
0
0%
6
2%
Albumin (gram (g)/L): <0.9×LLN
0
0%
1
0.3%
Alkaline Phosphatase (U/L): ≥3.0×ULN
0
0%
1
0.3%
Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase (SGOT)) (U/L): ≥3.0×ULN
2
1.4%
3
1%
Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×ULN
3
2%
2
0.7%
Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×LLN
3
2%
2
0.7%
Bicarbonate (HCO3) (millimole (mmol)/L): <0.9×LLN
6
4.1%
6
2%
Bilirubin, Total (micromole (umol)/L): >1.5×ULN
0
0%
1
0.3%
Blood Urea Nitrogen (mmol/L): >1.2×ULN
14
9.5%
27
8.9%
Calcium (mmol/L): >1.1×ULN
0
0%
1
0.3%
Chloride (mmol/L): <0.9×LLN
1
0.7%
1
0.3%
Cholesterol, Total, Fasting (mmol/L): >1.6×ULN
2
1.4%
5
1.7%
Creatinine (umol/L): >1.3×ULN
15
10.1%
20
6.6%
Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN
22
14.9%
52
17.2%
Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN
4
2.7%
14
4.6%
Glycohemoglobin A1C (%): Increase of ≥0.5%
95
64.2%
247
81.8%
Glycohemoglobin A1C (%): Increase of ≥1%
94
63.5%
246
81.5%
Phosphorus (mmol/L): >1.1×ULN
13
8.8%
5
1.7%
Phosphorus (mmol/L): <0.9×LLN
1
0.7%
4
1.3%
Potassium (mmol/L): <0.9×LLN
1
0.7%
0
0%
Protein, Total (g)/L): >1.1×ULN
1
0.7%
0
0%
Triglycerides, Fasting (mmol/L): ≥3.0×ULN
8
5.4%
9
3%
Uric Acid (Urate) (umol/L): >1.1×ULN
17
11.5%
37
12.3%
Uric Acid (Urate) (umol/L): <0.9×LLN
1
0.7%
9
3%
5. Primary Outcome
Title Number of Participants With Clinically Meaningful Trends for Vital Signs
Description Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
Time Frame Up to 52 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Measure Participants 145 299
Count of Participants [Participants]
0
0%
0
0%
6. Primary Outcome
Title Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Description A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Time Frame Up to 52 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Measure Participants 145 299
Count of Participants [Participants]
2
1.4%
2
0.7%
7. Primary Outcome
Title Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)
Description
Time Frame Up to 52 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Measure Participants 145 299
Count of Participants [Participants]
94
63.5%
246
81.5%
8. Primary Outcome
Title Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Description A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
Time Frame Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment (N=299 in the Relamorelin 10 μg arm). Anti-relamorelin antibody testing was only done for those participants who received treatment with relamorelin. Number analyzed is the number of participants with data available at the given timepoint. Due to a laboratory issue not all positive screening tests were confirmed.
Arm/Group Title Relamorelin 10 μg
Arm/Group Description Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Measure Participants 299
Negative
127
85.8%
Positive
39
26.4%
Negative
5
3.4%
Positive
0
0%
Negative
73
49.3%
Positive
23
15.5%
Negative
6
4.1%
Positive
1
0.7%
Negative
10
6.8%
Positive
4
2.7%
Negative
Positive
Negative
20
13.5%
Positive
6
4.1%
Negative
1
0.7%
Positive
0
0%
Negative
2
1.4%
Positive
1
0.7%
Negative
1
0.7%
Positive
0
0%

Adverse Events

Time Frame First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)
Adverse Event Reporting Description All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
All Cause Mortality
Placebo Relamorelin 10 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/148 (0%) 2/302 (0.7%)
Serious Adverse Events
Placebo Relamorelin 10 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 21/145 (14.5%) 43/299 (14.4%)
Cardiac disorders
Cardiac arrest 0/145 (0%) 2/299 (0.7%)
Acute left ventricular failure 1/145 (0.7%) 1/299 (0.3%)
Acute myocardial infarction 0/145 (0%) 1/299 (0.3%)
Angina pectoris 0/145 (0%) 1/299 (0.3%)
Angina unstable 0/145 (0%) 1/299 (0.3%)
Arteriosclerosis coronary artery 0/145 (0%) 1/299 (0.3%)
Atrial fibrillation 0/145 (0%) 1/299 (0.3%)
Bradycardia 0/145 (0%) 1/299 (0.3%)
Myocardial infarction 0/145 (0%) 1/299 (0.3%)
Cardiac failure 1/145 (0.7%) 0/299 (0%)
Sinus tachycardia 1/145 (0.7%) 0/299 (0%)
Congenital, familial and genetic disorders
Atrial septal defect 0/145 (0%) 1/299 (0.3%)
Ear and labyrinth disorders
Vertigo 0/145 (0%) 2/299 (0.7%)
Gastrointestinal disorders
Pancreatitis 1/145 (0.7%) 1/299 (0.3%)
Large intestine perforation 0/145 (0%) 1/299 (0.3%)
Abdominal pain upper 1/145 (0.7%) 0/299 (0%)
Constipation 1/145 (0.7%) 0/299 (0%)
Diabetic gastroparesis 1/145 (0.7%) 0/299 (0%)
Nausea 1/145 (0.7%) 0/299 (0%)
General disorders
Non-cardiac chest pain 0/145 (0%) 2/299 (0.7%)
Physical deconditioning 0/145 (0%) 1/299 (0.3%)
Hepatobiliary disorders
Cholelithiasis 0/145 (0%) 2/299 (0.7%)
Cholecystitis 1/145 (0.7%) 0/299 (0%)
Infections and infestations
Bronchitis 0/145 (0%) 2/299 (0.7%)
Diverticulitis 0/145 (0%) 2/299 (0.7%)
Sepsis 0/145 (0%) 2/299 (0.7%)
Pneumonia 2/145 (1.4%) 1/299 (0.3%)
Bacteraemia 0/145 (0%) 1/299 (0.3%)
COVID-19 0/145 (0%) 1/299 (0.3%)
Cellulitis 0/145 (0%) 1/299 (0.3%)
Diabetic gangrene 0/145 (0%) 1/299 (0.3%)
Herpes zoster 0/145 (0%) 1/299 (0.3%)
Metapneumovirus infection 0/145 (0%) 1/299 (0.3%)
Otitis media 0/145 (0%) 1/299 (0.3%)
Urinary tract infection 0/145 (0%) 1/299 (0.3%)
Urosepsis 0/145 (0%) 1/299 (0.3%)
Appendicitis 1/145 (0.7%) 0/299 (0%)
COVID-19 pneumonia 1/145 (0.7%) 0/299 (0%)
Diabetic foot infection 1/145 (0.7%) 0/299 (0%)
Gastroenteritis 1/145 (0.7%) 0/299 (0%)
Pneumonia pneumococcal 1/145 (0.7%) 0/299 (0%)
Injury, poisoning and procedural complications
Fall 0/145 (0%) 3/299 (1%)
Accidental overdose 0/145 (0%) 1/299 (0.3%)
Craniocerebral injury 0/145 (0%) 1/299 (0.3%)
Joint injury 0/145 (0%) 1/299 (0.3%)
Patella fracture 0/145 (0%) 1/299 (0.3%)
Animal bite 1/145 (0.7%) 0/299 (0%)
Road traffic accident 1/145 (0.7%) 0/299 (0%)
Upper limb fracture 1/145 (0.7%) 0/299 (0%)
Investigations
Blood glucose decreased 0/145 (0%) 1/299 (0.3%)
Blood glucose increased 0/145 (0%) 1/299 (0.3%)
Glomerular filtration rate decreased 0/145 (0%) 1/299 (0.3%)
Metabolism and nutrition disorders
Diabetic ketoacidosis 0/145 (0%) 2/299 (0.7%)
Dehydration 1/145 (0.7%) 1/299 (0.3%)
Hyperglycaemia 0/145 (0%) 1/299 (0.3%)
Hyperkalaemia 0/145 (0%) 1/299 (0.3%)
Hypoglycaemia 0/145 (0%) 1/299 (0.3%)
Hypokalaemia 1/145 (0.7%) 0/299 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration 0/145 (0%) 1/299 (0.3%)
Tendonitis 0/145 (0%) 1/299 (0.3%)
Osteoarthritis 1/145 (0.7%) 0/299 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin 0/145 (0%) 1/299 (0.3%)
Plasmacytoma 1/145 (0.7%) 0/299 (0%)
Nervous system disorders
Cervical radiculopathy 0/145 (0%) 1/299 (0.3%)
Headache 0/145 (0%) 1/299 (0.3%)
Migraine 0/145 (0%) 1/299 (0.3%)
Transient ischaemic attack 0/145 (0%) 1/299 (0.3%)
Vertebral artery occlusion 0/145 (0%) 1/299 (0.3%)
Cerebrovascular accident 1/145 (0.7%) 0/299 (0%)
Lumbar radiculopathy 1/145 (0.7%) 0/299 (0%)
Presyncope 1/145 (0.7%) 0/299 (0%)
Psychiatric disorders
Suicide attempt 0/145 (0%) 1/299 (0.3%)
Anxiety disorder 1/145 (0.7%) 0/299 (0%)
Major depression 1/145 (0.7%) 0/299 (0%)
Renal and urinary disorders
Acute kidney injury 0/145 (0%) 1/299 (0.3%)
Ureterolithiasis 0/145 (0%) 1/299 (0.3%)
Respiratory, thoracic and mediastinal disorders
Asthma 1/145 (0.7%) 3/299 (1%)
Skin and subcutaneous tissue disorders
Diabetic foot 1/145 (0.7%) 0/299 (0%)
Vascular disorders
Aortic stenosis 0/145 (0%) 1/299 (0.3%)
Hypertension 0/145 (0%) 1/299 (0.3%)
Hypotension 0/145 (0%) 1/299 (0.3%)
Peripheral arterial occlusive disease 0/145 (0%) 1/299 (0.3%)
Orthostatic hypotension 1/145 (0.7%) 0/299 (0%)
Other (Not Including Serious) Adverse Events
Placebo Relamorelin 10 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 37/145 (25.5%) 82/299 (27.4%)
Gastrointestinal disorders
Diarrhoea 14/145 (9.7%) 21/299 (7%)
Infections and infestations
Urinary tract infection 9/145 (6.2%) 28/299 (9.4%)
Metabolism and nutrition disorders
Hyperglycaemia 8/145 (5.5%) 15/299 (5%)
Musculoskeletal and connective tissue disorders
Arthralgia 11/145 (7.6%) 18/299 (6%)
Nervous system disorders
Headache 7/145 (4.8%) 15/299 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Therapeutic Area, Head
Organization Allergan
Phone 714-246-4500
Email clinicaltrials@allergan.com
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03383146
Other Study ID Numbers:
  • RLM-MD-04
  • 2017-002144-33
First Posted:
Dec 26, 2017
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021